Company
SingaporePfizer Asia Manufacturing Pte Ltd., Singapore, Singapore – FDA Inspections
Inspection records and compliance data for Pfizer Asia Manufacturing Pte Ltd. in Singapore. 6 FDA inspections on record, 2 Form 483s, last inspected October 27, 2021.
Company Profile
This profile covers Pfizer Asia Manufacturing Pte Ltd. based in Singapore, Singapore.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected March 19, 2009. Last inspected October 27, 2021.
Most cited issue areas
- Defined areas of adequate size for operations1 inspection
- Procedures not in writing, fully followed1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 27, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1156359 |
| March 15, 2019 | Not classified | Human Drugs | 1085293 |
| March 24, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1009110 |
| December 3, 2015 | NAI | Human Drugs · Drug Quality Assurance | 955761 |
| March 1, 2013 | NAI | Human Drugs · Drug Quality Assurance | 825350 |
| March 19, 2009 | NAI | Human Drugs · Drug Quality Assurance | 580783 |
FDA documents
Form 483s (2)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Pfizer Asia Manufacturing Pte Ltd.
FEI Number
3003901862
Address
31 Tuas South Avenue 6, Singapore, Singapore
Country
Singapore
ID: 77c4ecfd-af67-404b-8091-9c254525198b