FDA Inspection
BPI Labs LLCBPI Labs LLC – FDA Inspection, Apr 17, 2026
Record Details
This FDA Inspection record concerns BPI Labs LLC, with an inspection on April 17, 2026, issued by the Florida District Office, covering human drugs.
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ID · 745aa6f3-2cb1-48e1-82b0-d3e06dfb695a
Inspection Facts
- Inspection number
- 1312854
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- FDCA 503B(a)(2)Bulk drug substances, cannot be used in compounding
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Other FDA inspections of BPI Labs LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2025 | VAI | Florida District Office | Postmarketing Surveillance and Epidemiology: Human Drugs |
| February 21, 2025 | NAI | Florida District Office | Drug Quality Assurance |
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