FDA Inspection 1102272 — Ancorotti Cosmetics Srl
The FDA completed an inspection of Ancorotti Cosmetics Srl on Sep 19, 2019 in Crema. 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
- Sep 19, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Crema (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |