FDA Inspection 883317 — Adare Pharmaceuticals Srl
The FDA completed an inspection of Adare Pharmaceuticals Srl on May 30, 2014 in Pessano Con Bornago. 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
- May 30, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pessano Con Bornago (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 |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |