FDA Inspection 1102230 — MEIYUME (UK) Ltd.
The FDA completed an inspection of MEIYUME (UK) Ltd. on Sep 19, 2019 in Trowbridge. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 19, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Trowbridge (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 21294 | 21 CFR 211.110(b) | In-process specification, invalid |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |