945189
Qualgen, LLC — FEI 3011286349
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 17, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Edmond, OK (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |