FDA Inspection 912666 — Advanced Physician Solutions, Inc.
The FDA completed an inspection of Advanced Physician Solutions, Inc. on January 16, 2015 in N Hollywood, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 16, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- N Hollywood, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |