FDA Inspection
QuantiPharm IncQuantiPharm Inc – FDA Inspection, Nov 6, 2025
Record Details
This FDA Inspection record concerns QuantiPharm Inc, with an inspection on November 6, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 677cbc5c-26c6-43ce-91b3-9b55ca8d9200
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1290396
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
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