FDA Inspection
SGS India Private Ltd.SGS India Private Ltd. – FDA Inspection, May 28, 2014
Record Details
This FDA Inspection record concerns SGS India Private Ltd., with an inspection on May 28, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- SGS India Private Ltd.
- Inspection Date
- May 28, 2014
- Product Type
- Drugs
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ID · cb7f79b3-9cdd-4855-a077-a0d77b9e0567
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 881323
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of SGS India Private Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 7, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SGS India Private Ltd.
- FDA Inspection 1068643 - 2018-10-12
- FDA Inspection 701400 - 2010-10-07
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