FDA Inspection
SGS North America IncSGS North America Inc – FDA Inspection, Jun 23, 2017
Record Details
This FDA Inspection record concerns SGS North America Inc, with an inspection on June 23, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f98c4693-9fdb-4f43-9d08-0ac39dabe747
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015515
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of SGS North America Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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