FDA Inspection 988986 — Macau-Union Pharmaceutical Limited
The FDA completed an inspection of Macau-Union Pharmaceutical Limited on Sep 2, 2016 in Macao. 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). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 2, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Macao (Macao)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1797 | 21 CFR 211.82(a) | Examination on receipt, before acceptance |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |