FDA Inspection 880327 — Guna S.p.A.
The FDA completed an inspection of Guna S.p.A. on May 16, 2014 in Milan. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 16, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Milan (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 3596 | 21 CFR 211.122(g) | Failure to include one of special control procedures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |