FDA Inspection 1150563 — Hybrid Pharma LLC
The FDA completed an inspection of Hybrid Pharma LLC on Sep 3, 2021 in Deerfield Beach, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 3, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Deerfield Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 21423 | FDCA 503B(b)(2)(A) | Outsourcing facility, compounded drug report during registration |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |