FDA Inspection 759277 — Catalent U.K. Swindon Zydis Limited
The FDA completed an inspection of Catalent U.K. Swindon Zydis Limited on Nov 18, 2011 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 18, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Swindon (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |