FDA Inspection 1014041 — Qualgen, LLC
The FDA completed an inspection of Qualgen, LLC on May 10, 2017 in Edmond, OK. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 10, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Edmond, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |