FDA Inspection 821743 — UK Health Security Agency
The FDA completed an inspection of UK Health Security Agency on March 8, 2013 in Salisbury. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 8, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salisbury (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1852 | 21 CFR 211.94(a) | Reactive/Additive/Absorptive Containers/Closures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4316 | 21 CFR 211.84(d)(3) | Testing Containers & Closures Conformity with Specs |
| 4411 | 21 CFR 211.194(a)(6) | Test results, comparison with standards not included |