FDA Inspection
Bio Earth Manufacturing (PTY) Ltd.Bio Earth Manufacturing (PTY) Ltd. – FDA Inspection, Aug 22, 2019
Record Details
This FDA Inspection record concerns Bio Earth Manufacturing (PTY) Ltd., with an inspection on August 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5e1dbaa1-5d93-4a91-825e-247a40da4e35
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100158
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 111.255(b)Batch record - complete
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