Drug factory · FDA FEI 3003901862
Pfizer Asia Manufacturing Pte Ltd
11 Tuas Bay Street, Singapore, Singapore
Problems found, fixed voluntarily at FDA's last inspection, Oct 18, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 18, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 27, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 24, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 3, 2015 | No problems found | Drug Quality Assurance | — |
| Mar 1, 2013 | No problems found | Drug Quality Assurance | — |
| Mar 19, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 27, 2021 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Defined areas of adequate size for operations 21 CFR 211.42(c)
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
Registered with FDA for: analysis; api manufacture.