FDA Inspection 1267652 — BPI Labs, LLC
The FDA completed an inspection of BPI Labs, LLC on Apr 23, 2025 in Largo, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 23, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Largo, FL (United States)
Additional details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 21354 | FDCA 505-1(f)(3)(A) | Failure to comply with REMS Elements to Assure Safe Use (ETASU) A |