FDA Inspection 955743 — A. Nelson & Co., Ltd.
The FDA completed an inspection of A. Nelson & Co., Ltd. on Jan 29, 2016 in London. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 29, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- London (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2420 | 21 CFR 211.198(a) | Quality Control Review |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |