FDA Inspection
Po Sum On Medicine Factory LimitedPo Sum On Medicine Factory Limited – FDA Inspection, Jun 18, 2025
Record Details
This FDA Inspection record concerns Po Sum On Medicine Factory Limited, with an inspection on June 18, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 876b3d09-ff2b-42a5-9d39-377d0e283867
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1274838
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.180(f)Responsible firm officials notified in writing
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Po Sum On Medicine Factory Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 3, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 10, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Po Sum On Medicine Factory Limited
- FDA Inspection 1076446 - 2018-11-15
- FDA Inspection 896037 - 2014-09-03
- FDA Inspection 786899 - 2012-05-10
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