FDA Inspection 1107187 — Auro Pharmacies, Inc DBA Central Drugs
The FDA completed an inspection of Auro Pharmacies, Inc DBA Central Drugs on October 18, 2019 in La Habra, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 18, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- La Habra, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 21377 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical grade components |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4354 | 21 CFR 211.165(d) | Acceptance/Rejection Levels |