FDA Inspection 738728 — Advanced Generic Corporation
The FDA completed an inspection of Advanced Generic Corporation on Aug 1, 2011 in Miami, FL. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 1, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |