FDA Inspection
Solevy Co. LLCSolevy Co. LLC – FDA Inspection, May 3, 2024
Record Details
This FDA Inspection record concerns Solevy Co. LLC, with an inspection on May 3, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f49eae05-6eac-4c62-892b-7c44ba2b1f85
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1237580
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.84(d)(2)Component identification test
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Other FDA inspections of Solevy Co. LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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