FDA Inspection 1244664 — Accu Bio-Chem Laboratories LLC
The FDA completed an inspection of Accu Bio-Chem Laboratories LLC on Jul 30, 2024 in Glendale, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 30, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Glendale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2404 | 21 CFR 211.194(a)(6) | Comparison of Test Results to Specifications |