FDA Inspection 1150437 — Accu Bio-Chem Laboratories LLC
The FDA completed an inspection of Accu Bio-Chem Laboratories LLC on August 31, 2021 in Glendale, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 31, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Glendale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |