FDA Inspection 960084 — Wickham Micro Limited
The FDA completed an inspection of Wickham Micro Limited on February 17, 2016 in Gosport. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 17, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gosport (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |