FDA Inspection
Unipharm Inc.Unipharm Inc. – FDA Inspection, Nov 21, 2025
Record Details
This FDA Inspection record concerns Unipharm Inc., with an inspection on November 21, 2025, issued by the New England District Office, covering human drugs.
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ID · ec5f5086-bf96-4f87-a027-a8df3a71d1c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1292756
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Unipharm Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 5, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 28, 2021 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Unipharm Inc.
- FDA Inspection 1181213 - 2022-10-05
- FDA Inspection 1155937 - 2021-10-28
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