FDA Inspection 1249319 — Dextrum Laboratories
The FDA completed an inspection of Dextrum Laboratories on August 29, 2024 in Miami, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 29, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |