Karen Laboratorio, S.A. de C.V.
FDA import alert and refusal historyPueblo San Simon, MexicoFEI 3004274421
As of October 26, 2026, Karen Laboratorio, S.A. de C.V. is not on any FDA import alert in SupplierRadar's records; FDA refused 3 of its shipment lines between May 19, 2020 and May 26, 2020, most often for unauthorized nutrient content or health claim (HEALTH C).
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- Not listed
- Last import refusal
- Meal replacements (not labeled for treatment of disease) · LIST INGRE
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Karen Laboratorio, S.A. de C.V.
3 records, newest first. Each line links to the FDA page it came from.
2020
- Import refusalRefused, Meal replacements (not labeled for treatment of disease)LIST INGRELACKS FIRMLABELINGNUTRIT LBLHEALTH CUNAPPROVEDEntry CDP-0042081-2Source
- Import refusalRefused, Meal replacements (not labeled for treatment of disease)LIST INGREPLANT PARTNCONTACTNUTRIT LBLHEALTH CUNAPPROVEDEntry CDP-0041699-2Source
- Import refusalRefused, Meal replacements (not labeled for treatment of disease)LIST INGREDIETARYLBLPLANT PARTNCONTACTLABELINGNUTRIT LBLHEALTH CUNAPPROVEDEntry CDP-0041610-9Source
Refusal charges, in plain English
- HEALTH C3 refused lines
Unauthorized nutrient content or health claim
The label or labeling appeared to carry a nutrient content claim or health claim that is not authorized.
- LIST INGRE3 refused lines
Ingredients not listed
The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).
- NUTRIT LBL3 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.
- UNAPPROVED3 refused lines
Unapproved new drug
The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.
- LABELING2 refused lines
Fair Packaging and Labeling Act
The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.
- NCONTACT2 refused lines
No U.S. adverse event contact on supplement label
The dietary supplement label appeared not to show a U.S. address or phone number through which a serious adverse event can be reported.
- PLANT PART2 refused lines
PLANT PART
- DIETARYLBL1 refused line
Not identified as a dietary supplement
The label appeared not to identify the product with the term "dietary supplement" (which may be modified with the name of an ingredient).
Questions about Karen Laboratorio, S.A. de C.V.
- Is Karen Laboratorio, S.A. de C.V. on an FDA import alert?
- No listing for Karen Laboratorio, S.A. de C.V. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Mexico page.
- Has FDA refused shipments from Karen Laboratorio, S.A. de C.V.?
- Yes. FDA refused 3 shipment lines from Karen Laboratorio, S.A. de C.V. between May 19, 2020 and May 26, 2020. The most recent, on May 26, 2020, was meal replacements (not labeled for treatment of disease), charged as LIST INGRE (ingredients not listed).
- Why did FDA refuse Karen Laboratorio, S.A. de C.V.'s shipments?
- The most frequent charges are HEALTH C (unauthorized nutrient content or health claim, 3 lines) and LIST INGRE (ingredients not listed, 3 lines).
- What is Karen Laboratorio, S.A. de C.V.'s FEI number?
- Karen Laboratorio, S.A. de C.V.'s FDA Establishment Identifier (FEI) is 3004274421.
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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.