FDA Inspection
Terry SATerry SA – FDA Inspection, Nov 17, 2023
Record Details
This FDA Inspection record concerns Terry SA, with an inspection on November 17, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 822e136e-afee-4317-ba4e-e58bfa072b55
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1223076
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Terry SA
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Terry SA
- FDA Inspection 984440 - 2016-08-03
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