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Pfizer Asia Manufacturing Pte Ltd.

FDA Regulatory Profile

Pfizer Asia Manufacturing Pte Ltd. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Pfizer Asia Manufacturing Pte Ltd." and its spelling variant "Pfizer Asia Manufacturing". Records filed under related names are not included; see Related names.

Latest inspection
Oct 18, 2023 · VAI

Newer recall under related name Pfizer: Sep 29, 2026, D-0052-2027.

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections6Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Pfizer Asia Manufacturing Pte Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Pfizer Asia Manufacturing Pte Ltd.: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 0 inspections020192020: 0 inspections020202021: 1 inspections120212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202200000
202110000
202000000
201900000
201800000
201710000

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.

Recent FDA inspections

6 inspections from Mar 19, 2009 to Oct 18, 2023.

DateSiteProductClassificationFEI
Oct 18, 2023Singapore, SingaporeDrugsVoluntary Action Indicated (VAI)3003901862
Oct 27, 2021Singapore, SingaporeDrugsVoluntary Action Indicated (VAI)3003901862
Mar 24, 2017Singapore, SingaporeDrugsVoluntary Action Indicated (VAI)3003901862
Dec 3, 2015Singapore, SingaporeDrugsNo Action Indicated (NAI)3003901862
Mar 1, 2013Singapore, SingaporeDrugsNo Action Indicated (NAI)3003901862
Mar 19, 2009Singapore, SingaporeDrugsNo Action Indicated (NAI)3003901862
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.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3003901862Singapore, Singapore6Oct 18, 2023

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.