FDA Inspection 897773 — Catalent U.K. Swindon Zydis Limited
The FDA completed an inspection of Catalent U.K. Swindon Zydis Limited on Sep 12, 2014 in Swindon. 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
- Sep 12, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Swindon (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |