FDA Inspection
Quality Assistance SAQuality Assistance SA – FDA Inspection, Sep 17, 2019
Record Details
This FDA Inspection record concerns Quality Assistance SA, with an inspection on September 17, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3e38d625-2b52-406f-8fbb-720b90dd48da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102275
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Quality Assistance SA
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2025 | VAI | Drug Quality Assurance | |
| February 12, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 4, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 16, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Quality Assistance SA
- FDA Inspection 1302340 - 2025-09-04
- FDA Inspection 1278764 - 2021-02-12
- FDA Inspection 885462 - 2014-06-04
- FDA Inspection 651125 - 2010-02-16
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