FDA Inspection
Laleham Health & Beauty LimitedLaleham Health & Beauty Limited – FDA Inspection, Dec 18, 2014
Record Details
This FDA Inspection record concerns Laleham Health & Beauty Limited, with an inspection on December 18, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 18, 2014
- Product Type
- Drugs
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ID · a3761e92-2324-4618-b72c-01f34aa5a758
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 906974
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Laleham Health & Beauty Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 22, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Laleham Health & Beauty Limited
- FDA Inspection 1259764 - 2024-09-27
- FDA Inspection 784712 - 2012-03-22
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