FDA Inspection
Health Biotech LimitedHealth Biotech Limited – FDA Inspection, Dec 5, 2017
Record Details
This FDA Inspection record concerns Health Biotech Limited, with an inspection on December 5, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 1db70636-4369-4db1-8da8-5e838056a60a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1033847
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
21- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
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