Home / Companies / Pfizer Healthcare India Private Limited

Pfizer Healthcare India Private Limited FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Pfizer Healthcare India Private Limited has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Pfizer Healthcare India Private Limited, the most recent on Mar 25, 2020.

What these totals cover: FDA records filed under the name "Pfizer Healthcare India Private Limited".

Latest inspection: Oct 18, 2022 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	7	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Pfizer Healthcare India Private Limited's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	0	0	0
2023	0	0	0
2022	1	0	0
2021	0	0	0
2020	0	0	1
2019	1	1	0
2018	1	0	0
2017	1	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Reviewing Pfizer Healthcare India Private Limited as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Pfizer Healthcare India Private Limited yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Pfizer Healthcare India Private Limited FDA Warning Letters

1 warning letter on Mar 25, 2020.

Issued	Subject	Issuing office	Close-out letter
Mar 25, 2020 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

7 inspections from Mar 22, 2014 to Oct 18, 2022.

Date	Site	Product	Classification	FEI
Oct 18, 2022	Visakhapatnam, India	Drugs	Voluntary Action Indicated (VAI)	3008316085
Sep 6, 2019	Visakhapatnam, India	Drugs	Official Action Indicated (OAI)	3008316085
Sep 21, 2018	Visakhapatnam, India	Drugs	Voluntary Action Indicated (VAI)	3008316085
Mar 17, 2017	Visakhapatnam, India	Drugs	Voluntary Action Indicated (VAI)	3008316085
Sep 8, 2015	Visakhapatnam, India	Drugs	Voluntary Action Indicated (VAI)	3008316085
Feb 25, 2015	Visakhapatnam, India	Drugs	Voluntary Action Indicated (VAI)	3008316085
Mar 22, 2014	Visakhapatnam, India	Drugs	Voluntary Action Indicated (VAI)	3008316085

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Pfizer Healthcare India Private Limited: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Mar 25, 2020.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3008316085	Visakhapatnam, India	7	Oct 18, 2022

Pfizer Healthcare India Private Limited and the FDA: common questions

Has Pfizer Healthcare India Private Limited received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Pfizer Healthcare India Private Limited. The most recent is dated Mar 25, 2020.

Has Pfizer Healthcare India Private Limited received an FDA Form 483?

FDA has not published a Form 483 for "Pfizer Healthcare India Private Limited" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Pfizer Healthcare India Private Limited?

The most recent FDA inspection on file ended Oct 18, 2022 at Visakhapatnam, India and was classified VAI. FDA has 7 inspections of Pfizer Healthcare India Private Limited on file, 1 of them classified OAI (official action indicated).

Need more than this page shows? Ask about Pfizer Healthcare India Private Limited in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.