FDA Inspection
CHEMOTEST LABORATORYCHEMOTEST LABORATORY – FDA Inspection, Jan 29, 2025
Record Details
This FDA Inspection record concerns CHEMOTEST LABORATORY, with an inspection on January 29, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 186f62df-90da-4b56-a3cd-0a46956ea798
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1261134
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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