FDA Inspection
Afriplex (Pty) Ltd.Afriplex (Pty) Ltd. – FDA Inspection, Mar 28, 2025
Record Details
This FDA Inspection record concerns Afriplex (Pty) Ltd., with an inspection on March 28, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · f851062c-0a1a-4dbd-b99a-56a9e9f183c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1265915
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Afriplex (Pty) Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2013 | NAI | Center for Food Safety and Applied Nutrition | Pesticides and Chemical Contaminants |
Other documents for Afriplex (Pty) Ltd.
- FDA Inspection 835949 - 2013-06-18
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