FDA Inspection 1222392 — Hybrid Pharma LLC
The FDA completed an inspection of Hybrid Pharma LLC on November 9, 2023 in Deerfield Beach, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 9, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Deerfield Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1430 | 21 CFR 211.42(c)(10)(i) | Floors, walls, ceiling surfaces |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 22779 | FDCA 503B(b)(2)(A) | All inclusive product report, not submitted |
| 22783 | FDCA 503B(a)(2) | Bulk drug substances, cannot be used in compounding |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |