Abbott Laboratorios do Brasil Ltda

1 record, newest first. Each line links to the FDA page it came from.

Refusal charges, in plain English

• 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.

• 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 Abbott Laboratorios do Brasil Ltda

Is Abbott Laboratorios do Brasil Ltda on an FDA import alert?

No listing for Abbott Laboratorios do Brasil Ltda appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Brazil page.

Has FDA refused shipments from Abbott Laboratorios do Brasil Ltda?

Yes. FDA refused 1 shipment line from Abbott Laboratorios do Brasil Ltda on March 6, 2026. The most recent, on March 6, 2026, was mecobalamin (vitamin), charged as NOT LISTED (product not listed with fda).

Why did FDA refuse Abbott Laboratorios do Brasil Ltda's shipments?

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

What is Abbott Laboratorios do Brasil Ltda's FEI number?

Abbott Laboratorios do Brasil Ltda's FDA Establishment Identifier (FEI) is 3012330620.