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Pfizer Limited

FDA import alert and refusal historyMumbai, IndiaFEI 3012465412

Recorded by FDA as PFIZER LIMITED

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Example subjectPfizer Limite added to Import Alert 16-129 (red list)

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As of October 26, 2026, Pfizer Limited is not on any FDA import alert in SupplierRadar's records; FDA refused 4 of its shipment lines between September 9, 2020 and September 14, 2026, most often for unapproved new drug (UNAPPROVED).

Data from FDA public records, last checked . Request a correction

Current status

Import alerts
Not listed
Last import refusal
Vitamin, n.e.c. · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Pfizer Limited

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

2026

  1. Import refusal
    Refused, Vitamin, n.e.c.UNAPPROVEDEntry 1FX-3000427-0
    Source

2021

  1. Import refusal
    Refused, Vitamin, n.e.c.UNAPPROVEDEntry AEK-0120805-5
    Source
  2. Import refusal
    Refused, Vitamin b1 (thiamine)UNAPPROVEDEntry 799-5083577-6
    Source

2020

  1. Import refusal
    Refused, Multiple vitamins (mvi-12 vitamin combo) (vitamin)UNAPPROVEDEntry 799-8045612-1
    Source

Refusal charges, in plain English

  • UNAPPROVED4 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.

Questions about Pfizer Limited

Is Pfizer Limited on an FDA import alert?
No listing for Pfizer Limited appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the India page.
Has FDA refused shipments from Pfizer Limited?
Yes. FDA refused 4 shipment lines from Pfizer Limited between September 9, 2020 and September 14, 2026. The most recent, on September 14, 2026, was vitamin, n.e.c., charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Pfizer Limited's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 4 lines).
What is Pfizer Limited's FEI number?
Pfizer Limited's FDA Establishment Identifier (FEI) is 3012465412.

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Example subjectPfizer Limite added to Import Alert 16-129 (red list)

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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.