FDA Inspection 1197661 — E5 Pharma LLC
The FDA completed an inspection of E5 Pharma LLC on February 17, 2023 in Boca Raton, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 17, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Boca Raton, FL (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 10022 | 21 CFR 310.305(a) | Failure to develop written procedures |
| 6705 | 21 CFR 310.305(c) | Failure to submit ADE report |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6833 | 21 CFR 314.80(c)(2)(ii)(A) | Incomplete periodic safety report |