Olnatura, S. A. de C. V.
FDA import alert and refusal historyJiutepec, MexicoFEI 3010626657
As of October 26, 2026, Olnatura, S. A. de C. V. (Jiutepec, Mexico) is on the red list of FDA Import Alert 99-39 (Imported foods that appear to be misbranded) for dietgenix shake (chocolate); biogaxtric; biofiberex, published by FDA on November 16, 2015, is also listed on Import Alert 54-14 (red list) and Import Alert 99-22 (red list), and has 3 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Last import refusal
- Vitamin c (ascorbic acid) · SUPPL GMP
- Last warning letter
- None found
- Last inspection
- Classified OAI (Official Action Indicated)
Every FDA record for Olnatura, S. A. de C. V.
7 records, newest first. Each line links to the FDA page it came from.
2026
2020
- Import refusalRefused, Folic acid (vitamin)UNAPPROVEDEntry AEK-8158309-5Source
2015
- Import alert listingListed on Import Alert 99-39red listDietgenix Shake (Chocolate); Biogaxtric; BiofiberexSource
- Import alert listingListed on Import Alert 54-14red listAll Vit/Min/Prot/Unconv Diet (Human/Animal)Source
- Import alert listingListed on Import Alert 99-22red listBiofiberexSource
- InspectionInspection classified OAI (Official Action Indicated)Food Composition, Standards, Labeling and EconSource
Refusal charges, in plain English
- SUPPL GMP2 refused lines
Dietary supplement CGMP not met
The product appeared to be a dietary supplement prepared, packed, or held under conditions that do not meet current good manufacturing practice (CGMP) regulations.
- UNAPPROVED1 refused line
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.
Questions about Olnatura, S. A. de C. V.
- Is Olnatura, S. A. de C. V. on an FDA import alert?
- Yes. As of October 26, 2026, Olnatura, S. A. de C. V. is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for dietgenix shake (chocolate); biogaxtric; biofiberex; FDA published the listing on November 16, 2015.
- Has FDA refused shipments from Olnatura, S. A. de C. V.?
- Yes. FDA refused 3 shipment lines from Olnatura, S. A. de C. V. between December 17, 2020 and July 9, 2026. The most recent, on July 9, 2026, was vitamin c (ascorbic acid), charged as SUPPL GMP (dietary supplement cgmp not met).
- Why did FDA refuse Olnatura, S. A. de C. V.'s shipments?
- The most frequent charges are SUPPL GMP (dietary supplement cgmp not met, 2 lines) and UNAPPROVED (unapproved new drug, 1 line).
- When was Olnatura, S. A. de C. V. last inspected by FDA?
- FDA's most recent inspection of Olnatura, S. A. de C. V. with a final classification is dated April 14, 2015 and was classified OAI (Official Action Indicated).
- What is Olnatura, S. A. de C. V.'s FEI number?
- Olnatura, S. A. de C. V.'s FDA Establishment Identifier (FEI) is 3010626657.
- Can shipments from Olnatura, S. A. de C. V. still enter the U.S.?
- Shipments of dietgenix shake (chocolate); biogaxtric; biofiberex from Olnatura, S. A. de C. V. can be detained without physical examination under Import Alert 99-39; 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).
Buying from Olnatura, S. A. de C. V.?
Watch it and get the FDA record the day it changes. Free for one supplier.
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.