FDA Inspection 1115592 — Eosera, Inc.
The FDA completed an inspection of Eosera, Inc. on Jan 17, 2020 in Fort Worth, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 17, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1849 | 21 CFR 211.84(d)(6) | Objectionable microbiological contamination |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |