FDA Inspection
API Solutions Inc.API Solutions Inc. – FDA Inspection, Apr 10, 2019
Record Details
This FDA Inspection record concerns API Solutions Inc., with an inspection on April 10, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · cd86160d-057d-42ca-b05f-762c78325fbb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086250
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.166(a)Lack of written stability program
Full citation text and observation details available on the Dashboard.
Other FDA inspections of API Solutions Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 31, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for API Solutions Inc.
- FDA Inspection 985059 - 2016-08-31
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