FDA Inspection 901969 — Istituto De Angeli Srl
The FDA completed an inspection of Istituto De Angeli Srl on Oct 31, 2014 in Reggello. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 31, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Reggello (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1957 | 21 CFR 211.180(e)(2) | Review of problem drugs |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |