Abbott Laboratories de Mexico, S.A. de C.V.

4 records, newest first. Each line links to the FDA page it came from.

Refusal charges, in plain English

• UNAPPROVED2 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.

• NOT LISTED1 refused line

  Product not listed with FDA

  The product appeared to be a drug or device that is not included in the listing FDA requires under section 510(j) of the FD&C Act.

Questions about Abbott Laboratories de Mexico, S.A. de C.V.

Is Abbott Laboratories de Mexico, S.A. de C.V. on an FDA import alert?

Yes. As of October 26, 2026, Abbott Laboratories de Mexico, S.A. de C.V. is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for peach flavor pedialyte; orange flavor pedialyte; pedialyte cherry flavor; pedialyte pineapple flavor; pedialyte of durazno; FDA published the listing on September 18, 2009.

Has FDA refused shipments from Abbott Laboratories de Mexico, S.A. de C.V.?

Yes. FDA refused 2 shipment lines from Abbott Laboratories de Mexico, S.A. de C.V. between October 6, 2016 and February 27, 2024. The most recent, on February 27, 2024, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as NOT LISTED (product not listed with fda).

Why did FDA refuse Abbott Laboratories de Mexico, S.A. de C.V.'s shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 2 lines) and NOT LISTED (product not listed with fda, 1 line).

When was Abbott Laboratories de Mexico, S.A. de C.V. last inspected by FDA?

FDA's most recent inspection of Abbott Laboratories de Mexico, S.A. de C.V. with a final classification is dated April 7, 2026 and was classified NAI (No Action Indicated).

What is Abbott Laboratories de Mexico, S.A. de C.V.'s FEI number?

Abbott Laboratories de Mexico, S.A. de C.V.'s FDA Establishment Identifier (FEI) is 3007262154.

Can shipments from Abbott Laboratories de Mexico, S.A. de C.V. still enter the U.S.?

Shipments of peach flavor pedialyte; orange flavor pedialyte; pedialyte cherry flavor; pedialyte pineapple flavor; pedialyte of durazno from Abbott Laboratories de Mexico, S.A. de C.V. can be detained without physical examination under Import Alert 45-02; 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).