FDA Inspection 1020341 — Bray Group Limited
The FDA completed an inspection of Bray Group Limited on August 4, 2017 in Faringdon. 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
- August 4, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Faringdon (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1770 | 21 CFR 211.137(d) | Expiration date location on labeling |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4324 | 21 CFR 211.110(b) | In-process materials specifications testing |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |