FDA Inspection
Pearmine Health LtdPearmine Health Ltd – FDA Inspection, Sep 19, 2025
Record Details
This FDA Inspection record concerns Pearmine Health Ltd, with an inspection on September 19, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 49d115df-e8f7-4c8a-a01d-31596b043a58
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1282386
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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