FDA Inspection
Bray Group LimitedBray Group Limited – FDA Inspection, Aug 4, 2017
Record Details
This FDA Inspection record concerns Bray Group Limited, with an inspection on August 4, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7b18c504-9580-4dc4-9b5c-c8f23a6657b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1020341
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.137(d)Expiration date location on labeling
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.110(b)In-process materials specifications testing
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Bray Group Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bray Group Limited
- FDA Inspection 1159676 - 2021-09-30
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