Pfizer Healthcare India Private Limited
FDA inspection history across 2 sites, 2019 to 2023
- 2
- Close-outs
- 2
- Form 483s
Every document, by year
- Close-out
- Form 483
2019: one Form 483; 2020: one close-out letter; 2022: one Form 483; 2023: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–23Two Form 483s and two close-out letters, at Visakhapatnam, India and New York, New York.
- 2022The longest 483 on file: 1 observation over 3 pages at Visakhapatnam, India.
Cited most
Across all Pfizer Healthcare India Private Limited observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.63Equipment design, size, and location1
The complete Pfizer Healthcare India Private Limited file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
New York, New York
Two close-out letters · 2020 to 2023
Latest: Close-out, Feb 8, 2023 →Visakhapatnam, India
Two Form 483s · 2019 to 2022 · 1 observation
Latest: Form 483, Oct 18, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-02-08 | Close-out Close-out letter | New York, New York | — | $99 |
| 2022-10-18 | 483 Form 483 | Visakhapatnam, India | 1 | $99 |
| 2020-03-25 | Close-out Close-out letter | New York, New York | — | $99 |
| 2019-09-06 | 483 Form 483 | Visakhapatnam, India | — | $99 |
Investigators on these documents
FEI number 3008316085 · most recent document Feb 8, 2023
About Pfizer Healthcare India Private Limited
How many FDA Form 483s has Pfizer Healthcare India Private Limited received?
FDA Intel has 2 Form 483s on file for Pfizer Healthcare India Private Limited; the most recent is dated Oct 18, 2022.
When was Pfizer Healthcare India Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Pfizer Healthcare India Private Limited is a Form 483 dated Oct 18, 2022, for the site in Visakhapatnam, India.
What did FDA cite at Pfizer Healthcare India Private Limited?
The regulations cited most in the observations on file for Pfizer Healthcare India Private Limited are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.