FDA Inspection 952513 — Catalent Anagni SRL
The FDA completed an inspection of Catalent Anagni SRL on November 20, 2015 in Anagni. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 20, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Anagni (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |