Hipp GmbH & CO Vertrieb KG
FDA import alert and refusal historyPfaffenhofen A.d.ilm, GermanyFEI 3012517425
As of October 26, 2026, Hipp GmbH & CO Vertrieb KG (Pfaffenhofen A.d.ilm, Germany) is on the red list of FDA Import Alert 40-05 (Adulterated and misbranded infant formula) for hipp combiotic pre infant milk, published by FDA on April 3, 2019, is also listed on Import Alert 99-39 (red list), and has 134 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- IA 40-05 · red listIA 99-39 · red list
- Last import refusal
- Milk base infant formula product (0-12 months), ready to feed · LACK NOTIF
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Hipp GmbH & CO Vertrieb KG
136 records, newest first. Each line links to the FDA page it came from.
2026
- Import refusalRefused, Milk base infant formula product (0-12 months), ready to feedLACK NOTIFFALSENO ENGLISHEntry 1FX-0510425-2Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaINCONSPICULACKS N/CEntry 1FX-6434775-9Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaINCONSPICULACKS N/CEntry 1FX-6075268-9Source
- Import refusalSource
Refused, 3 lines in one entry: Vegetables, n.e.c. (baby); Fruit flavored drinkNEEDS FCENO PROCESSEntry 1FX-2772482-2Show 3 linesHide lines
- Refused, Vegetables, n.e.c. (baby)NEEDS FCENO PROCESSEntry 1FX-2772482-2Source
- Refused, Vegetables, n.e.c. (baby)NEEDS FCENO PROCESSEntry 1FX-2772482-2Source
- Refused, Fruit flavored drinkNEEDS FCENO PROCESSEntry 1FX-2772482-2Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHNUTR DEFNUTR UNITEntry 1FX-4646546-3Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFNO ENGLISHNUTRIT LBLEntry 1FX-6715369-1Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry 1FX-4647092-7Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry 1FX-1341743-0Source
- Import refusalRefused, Milk base infant formula product (0-12 months), ready to feedNUTRIT LBLEntry 799-7289481-3Source
- Import refusalRefused, Other formula products, n.e.c., ready to feedLABELINGEntry 799-7532441-2Source
- Import refusalRefused, Milk base infant formula product (0-12 months), ready to feedLABELINGEntry 799-8771133-3Source
- Import refusalRefused, Whey base infant formula product (0-12 months), ready to feedFALSENO ENGLISHEntry 1FX-4556935-6Source
- Import refusalRefused, Other formula products, n.e.c., ready to feedFALSEEntry SCS-5934025-2Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry 799-3531442-0Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFINCONSPICUNO ENGLISHEntry SCS-4501974-7Source
Show 119 earlier records (2016–2026)Hide earlier records
2026
- Import refusalRefused, Other formula products, n.e.c., ready to feedLACK NOTIFFALSEEntry 799-8566012-8Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFFALSEEntry 799-9973381-2Source
- Import refusalRefused, Other formula products, n.e.c., ready to feedFALSEEntry 799-8713609-3Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry 799-8410833-5Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry SCS-7723481-8Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFFALSENO ENGLISHEntry 799-3651436-6Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaNUTRIT LBLEntry 799-4562832-2Source
- Import refusalRefused, Whey base infant formula product (0-12 months), ready to feedLACK NOTIFNO ENGLISHEntry 799-3058245-0Source
2025
- Import refusalRefused, Other formula products, n.e.c., ready to feedLACK NOTIFINCONSPICUNO ENGLISHNUTRIT LBLEntry SCS-7084255-9Source
- Import refusalRefused, Baby and junior food n.e.c.FALSELACKS N/CNUTRIT LBLEntry SCS-5250284-1Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaINCONSPICUFALSEEntry 799-2982664-4Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry SCS-6363669-5Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaFALSELACKS N/CNO ENGLISHEntry 799-1255675-2Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry 799-4064763-1Source
- Import refusalSource
Refused, 3 lines in one entry: Other formula products, n.e.c., powder formula; Baked goods, n.e.c. (baby)FALSENO ENGLISHEntry SCS-3952086-6Show 3 linesHide lines
- Refused, Other formula products, n.e.c., powder formulaFALSENO ENGLISHEntry SCS-3952086-6Source
- Refused, Other formula products, n.e.c., powder formulaFALSENO ENGLISHEntry SCS-3952086-6Source
- Refused, Baked goods, n.e.c. (baby)FALSENO ENGLISHEntry SCS-3952086-6Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry SCS-5170916-5Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFINCONSPICUFALSELACKS N/CNO ENGLISHEntry SCS-4617071-3Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry SCS-4620642-6Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaNUTR DEFEntry SCS-0667951-3Source
- Import refusalRefused, Other formula products, n.e.c., ready to feedNUTR UNITEntry 799-0372259-5Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaINCONSPICUFALSEEntry SCS-1919720-6Source
- Import refusalRefused, Other formula products, n.e.c., ready to feedNO ENGLISHNUTRIT LBLEntry 799-7410016-7Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaFILTHYEntry SCS-9158757-0Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CEntry 799-7277774-3Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry SCS-0101195-1Source
- Import refusalSource
Refused, 5 lines in one entry: Milk base infant formula product (0-12 months), powder formulaFALSEEntry SCS-6709000-5Show 5 linesHide lines
- Refused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry SCS-6709000-5Source
- Refused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry SCS-6709000-5Source
- Refused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry SCS-6709000-5Source
- Refused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry SCS-6709000-5Source
- Refused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry SCS-6709000-5Source
2024
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry SCS-7303356-9Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry SCS-7135390-2Source
- Import refusalSource
Refused, 2 lines in one entry: Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry SCS-6641379-4Show 2 linesHide lines
- Refused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry SCS-6641379-4Source
- Refused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry SCS-6641379-4Source
- Import refusalSource
Refused, 3 lines in one entry: Milk base infant formula product (0-12 months), powder formulaLACK NOTIFEntry 799-4110168-6Show 3 linesHide lines
- Refused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFEntry 799-4110168-6Source
- Refused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFEntry 799-4110168-6Source
- Refused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFEntry 799-4110168-6Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry SCS-6448540-6Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry SCS-5480869-0Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry SCS-4779611-9Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaFALSENO ENGLISHNUTR DEFNUTRIT LBLEntry 799-7711812-4Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry SCS-2220547-4Source
- Import refusalRefused, Goat milk infant based formula product (0-12 months), powder formulaNO ENGLISHEntry SCS-2319565-8Source
- Import refusalRefused, Baby and junior food n.e.c.FALSENUTRIT LBLEntry SCS-2809502-8Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry 799-8226217-2Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaINCONSPICULACKS N/CEntry SCS-2321058-0Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry 799-7717587-6Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry 799-7693902-5Source
2023
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHNUTR UNITNUTRIT LBLEntry 799-7650416-7Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaFALSENO ENGLISHEntry 799-7691757-5Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaFALSELACKS N/CNO ENGLISHEntry 799-7714158-9Source
- Import refusalRefused, Milk base infant formula product (0-12 months), ready to feedINCONSPICUFALSEEntry 799-2986693-7Source
2022
- Import refusalRefused, Milk, driedFALSENO ENGLISHEntry 799-1513431-6Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry SCS-2443525-0Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHNUTRIT LBLEntry 799-8220997-4Source
2021
- Import refusalRefused, Milk base infant formula product (0-12 months), ready to feedFALSEEntry SCS-8832285-6Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFNO ENGLISHNUTRIT LBLEntry 799-5378997-0Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFLACKS N/CNO ENGLISHNUTRIT LBLEntry 799-5761385-3Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFNO ENGLISHNUTRIT LBLEntry SCS-7413744-1Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry AEK-9519683-5Source
- Import refusalSource
Refused, 5 lines in one entry: Grain snacks (whole, split), n.e.c., baked; Vine fruits, mixed, juices or concentrates and 2 moreNO ENGLISHNUTRIT LBLEntry SCS-6097388-2Show 5 linesHide lines
- Refused, Grain snacks (whole, split), n.e.c., bakedNO ENGLISHNUTRIT LBLEntry SCS-6097388-2Source
- Refused, Vine fruits, mixed, juices or concentratesNO ENGLISHNUTRIT LBLEntry SCS-6097388-2Source
- Refused, Grain snacks (whole, split), n.e.c., bakedNO ENGLISHNUTRIT LBLEntry SCS-6097388-2Source
- Refused, Fruit snack foods, n.e.c., fried/oil cookedNO ENGLISHNUTRIT LBLEntry SCS-6097388-2Source
- Refused, Plain cookies,biscuits and wafers, n.e.c.NO ENGLISHNUTRIT LBLEntry SCS-6097388-2Source
2020
2019
- Import refusalRefused, Milk base infant formula product (0-12 months), ready to feedNO ENGLISHEntry AEK-4224288-0Source
- Import refusalRefused, Milk base infant formula product (0-12 months), ready to feedNO ENGLISHEntry AEK-5824578-5Source
- Import refusalRefused, Milk base infant formula product (0-12 months), ready to feedINCONSPICUEntry AEK-5815827-7Source
- Import refusalRefused, Infant formula raw material component, n.e.c.,FALSENO ENGLISHNUTRIT LBLEntry AEK-6327050-5Source
- Import refusalRefused, Milk base infant formula product (0-12 months), ready to feedNO ENGLISHEntry AEK-5990321-8Source
- Import alert listingListed on Import Alert 40-05red listHiPP Combiotic PRE Infant MilkSource
- Import refusalRefused, Milk base infant formula product (0-12 months), ready to feedFALSEEntry AEK-5571898-2Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaINCONSPICUEntry AEK-5605235-7Source
2018
- Import refusalSource
Refused, 2 lines in one entry: Baby and junior food n.e.c.NO ENGLISHEntry 799-5738352-1Show 2 linesHide lines
- Refused, Baby and junior food n.e.c.NO ENGLISHEntry 799-5738352-1Source
- Refused, Baby and junior food n.e.c.NO ENGLISHEntry 799-5738352-1Source
- Import refusalRefused, Milk base infant formula product (0-12 months), ready to feedINCONSPICUEntry AEK-4409903-1Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry AEK-4339304-7Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry 799-4401701-8Source
- Import refusalRefused, Milk base infant formula product (0-12 months), ready to feedNO ENGLISHEntry AEK-4248463-1Source
2017
- Import refusalRefused, Milk base infant formula product (0-12 months), ready to feedFALSELABELINGEntry AEK-3563844-1Source
- Import refusalSource
Refused, 9 lines in one entry: Wheat cereal (baby); Milk base infant formula product (0-12 months), powder formula and 1 moreLIST INGRELACKS FIRMLACKS N/CNO ENGLISHEntry 799-9354596-6Show 9 linesHide lines
- Refused, Wheat cereal (baby)LIST INGRELACKS FIRMLACKS N/CNO ENGLISHUSUAL NAMEALLERGENNUTRIT LBLEntry 799-9354596-6Source
- Refused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHUSUAL NAMEALLERGENNUTRIT LBLEntry 799-9354596-6Source
- Refused, Wheat cereal (baby)LIST INGRELACKS FIRMLACKS N/CNO ENGLISHUSUAL NAMEALLERGENNUTRIT LBLEntry 799-9354596-6Source
- Refused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHUSUAL NAMEALLERGENNUTRIT LBLEntry 799-9354596-6Source
- Refused, Instant cereal made with formula (baby)LACKS N/CNO ENGLISHUSUAL NAMEALLERGENNUTRIT LBLEntry 799-9354596-6Source
- Refused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHUSUAL NAMEALLERGENNUTRIT LBLEntry 799-9354596-6Source
- Refused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHUSUAL NAMEALLERGENNUTRIT LBLEntry 799-9354596-6Source
- Refused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHUSUAL NAMEALLERGENNUTRIT LBLEntry 799-9354596-6Source
- Refused, Instant cereal made with formula (baby)LACKS N/CNO ENGLISHUSUAL NAMEALLERGENNUTRIT LBLEntry 799-9354596-6Source
- Import refusalRefused, Baby and junior food n.e.c.LIST INGRELACKS FIRMLACKS N/CNO ENGLISHALLERGENNUTRIT LBLEntry 799-9476914-4Source
- Import refusalRefused, Baby and junior food n.e.c.LIST INGRELACKS FIRMLACKS N/CNO ENGLISHUSUAL NAMEALLERGENNUTRIT LBLEntry 799-9196355-9Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS FIRMLACKS N/CNO ENGLISHUSUAL NAMEALLERGENNUTRIT LBLEntry 799-8963790-0Source
- Import refusalRefused, Rice flakes,puffs,krispies,loops ready to eatNUTRIT LBLEntry 799-0423122-6Source
- Import refusalSource
Refused, 4 lines in one entry: Baby and junior food n.e.c.; Cereal preparations not elsewhere mentioned, n.e.c.NO ENGLISHEntry 799-9460064-6Show 4 linesHide lines
- Refused, Baby and junior food n.e.c.NO ENGLISHEntry 799-9460064-6Source
- Refused, Baby and junior food n.e.c.NO ENGLISHEntry 799-9460064-6Source
- Refused, Baby and junior food n.e.c.NO ENGLISHEntry 799-9460064-6Source
- Refused, Cereal preparations not elsewhere mentioned, n.e.c.NO ENGLISHEntry 799-9460064-6Source
- Import refusalSource
Refused, 2 lines in one entry: Milk base infant formula product (0-12 months), powder formulaNUTRIT LBLNO PROCESSEntry 799-9442446-8Show 2 linesHide lines
- Refused, Milk base infant formula product (0-12 months), powder formulaNUTRIT LBLNO PROCESSEntry 799-9442446-8Source
- Refused, Milk base infant formula product (0-12 months), powder formulaNUTRIT LBLNO PROCESSEntry 799-9442446-8Source
- Import refusalRefused, Baby and junior food n.e.c.LIST INGRELACKS FIRMLACKS N/CNO ENGLISHUSUAL NAMEALLERGENNUTRIT LBLEntry 799-9476724-7Source
- Import refusalRefused, Other formula products, n.e.c., powder formulaINCONSPICULACKS N/CNO ENGLISHNUTRIT LBLEntry 799-9388236-9Source
- Import alert listingListed on Import Alert 99-39red listInfant Formula HiPP Bio Combiotik stage 1Source
- Import refusalSource
Refused, 3 lines in one entry: Cereal preparations not elsewhere mentioned, n.e.c.LIST INGRELACKS FIRMNO ENGLISHUSUAL NAMEEntry 799-8302499-8Show 3 linesHide lines
- Refused, Cereal preparations not elsewhere mentioned, n.e.c.LIST INGRELACKS FIRMNO ENGLISHUSUAL NAMENUTRIT LBLEntry 799-8302499-8Source
- Refused, Cereal preparations not elsewhere mentioned, n.e.c.LIST INGRELACKS FIRMNO ENGLISHUSUAL NAMENUTRIT LBLEntry 799-8302499-8Source
- Refused, Cereal preparations not elsewhere mentioned, n.e.c.LIST INGRELACKS FIRMNO ENGLISHUSUAL NAMENUTRIT LBLEntry 799-8302499-8Source
- Import refusalSource
Refused, 6 lines in one entry: Baby and junior food n.e.c.NO ENGLISHLACKS N/CUSUAL NAMENUTRIT LBLEntry 799-8288538-1Show 6 linesHide lines
- Refused, Baby and junior food n.e.c.NO ENGLISHEntry 799-8288538-1Source
- Refused, Baby and junior food n.e.c.NO ENGLISHEntry 799-8288538-1Source
- Refused, Baby and junior food n.e.c.LACKS N/CNO ENGLISHUSUAL NAMENUTRIT LBLEntry 799-8288538-1Source
- Refused, Baby and junior food n.e.c.NO ENGLISHEntry 799-8288538-1Source
- Refused, Baby and junior food n.e.c.NO ENGLISHEntry 799-8288538-1Source
- Refused, Baby and junior food n.e.c.NO ENGLISHEntry 799-8288538-1Source
2016
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHUSUAL NAMENUTRIT LBLEntry 799-7879330-0Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaSTD IDENTLACKS N/CNO ENGLISHNUTRIT LBLEntry 799-7606309-4Source
- Import refusalRefused, Milk base infant formula product (0-12 months), powder formulaSTD IDENTLACKS N/CNO ENGLISHNUTRIT LBLEntry 799-7618170-6Source
Refusal charges, in plain English
- NO ENGLISH85 refused lines
Required label information not in English
Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.
- LACKS N/C43 refused lines
Net quantity statement missing
The packaged food appeared not to carry an accurate statement of the quantity of contents, such as net weight, measure, or count, on its label.
- NUTRIT LBL43 refused lines
Nutrition information missing from label
The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.
- FALSE38 refused lines
False or misleading labeling
The labeling appeared to be false or misleading in some particular.
- USUAL NAME17 refused lines
Common or usual name missing
The label appeared not to show the common or usual name of the food.
- LACK NOTIF15 refused lines
LACK NOTIF
- ALLERGEN13 refused lines
Major food allergen not declared
The label appeared not to declare all major food allergens present in the product, as section 403(w) of the FD&C Act requires.
- INCONSPICU13 refused lines
Required information not conspicuous
Information required on the label appeared not to be placed prominently or conspicuously enough to be read and understood by an ordinary consumer.
Questions about Hipp GmbH & CO Vertrieb KG
- Is Hipp GmbH & CO Vertrieb KG on an FDA import alert?
- Yes. As of October 26, 2026, Hipp GmbH & CO Vertrieb KG is on the red list of FDA Import Alert 40-05, “Adulterated and misbranded infant formula”, for hipp combiotic pre infant milk; FDA published the listing on April 3, 2019.
- Has FDA refused shipments from Hipp GmbH & CO Vertrieb KG?
- Yes. FDA refused 134 shipment lines from Hipp GmbH & CO Vertrieb KG between November 3, 2016 and July 22, 2026. The most recent, on July 22, 2026, was milk base infant formula product (0-12 months), ready to feed, charged as LACK NOTIF (lack notif).
- Why did FDA refuse Hipp GmbH & CO Vertrieb KG's shipments?
- The most frequent charges are NO ENGLISH (required label information not in english, 85 lines) and LACKS N/C (net quantity statement missing, 43 lines).
- What is Hipp GmbH & CO Vertrieb KG's FEI number?
- Hipp GmbH & CO Vertrieb KG's FDA Establishment Identifier (FEI) is 3012517425.
- Can shipments from Hipp GmbH & CO Vertrieb KG still enter the U.S.?
- Shipments of hipp combiotic pre infant milk from Hipp GmbH & CO Vertrieb KG can be detained without physical examination under Import Alert 40-05; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).
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