FDA Inspection 1107187 — Auro Pharmacies, Inc
The FDA completed an inspection of Auro Pharmacies, Inc on Oct 18, 2019 in La Habra, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 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 |