Pfizer Asia Manufacturing Pte Ltd.
FDA inspection history in Singapore, Singapore, 2019 to 2021
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21Two Form 483s, at Singapore, Singapore.
- 2019The longest 483 on file: 6 observations over 4 pages at Singapore, Singapore.
Cited most
Across all Pfizer Asia Manufacturing Pte observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.180General requirements1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
The complete Pfizer Asia Manufacturing Pte file.
All 2 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
Singapore, Singapore
Two Form 483s · 2019 to 2021 · 8 observations
Latest: Form 483, Oct 27, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-10-27 | 483 Form 483 | Singapore, Singapore | 2 | $99 |
| 2019-03-15 | 483 Form 483 | Singapore, Singapore | 6 | $99 |
Investigators on these documents
FEI number 3003901862 · most recent document Oct 27, 2021
About Pfizer Asia Manufacturing Pte Ltd.
How many FDA Form 483s has Pfizer Asia Manufacturing Pte Ltd. received?
FDA Intel has 2 Form 483s on file for Pfizer Asia Manufacturing Pte Ltd.; the most recent is dated Oct 27, 2021.
When was Pfizer Asia Manufacturing Pte Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Pfizer Asia Manufacturing Pte Ltd. is a Form 483 dated Oct 27, 2021, for the site in Singapore, Singapore.
What did FDA cite at Pfizer Asia Manufacturing Pte Ltd.?
The regulations cited most in the observations on file for Pfizer Asia Manufacturing Pte Ltd. are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.180 (General requirements), 1 time; 21 CFR 211.188 (Batch production and control records), 1 time.