FDA Inspection
ProSolus IncProSolus Inc – FDA Inspection, Jul 25, 2025
Record Details
This FDA Inspection record concerns ProSolus Inc, with an inspection on July 25, 2025, issued by the Florida District Office, covering human drugs.
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ID · e56ff90c-6034-45e0-bb1c-c58dc02d3587
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1276536
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of ProSolus Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ProSolus Inc
- FDA Inspection 1083286 - 2019-03-06
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