956318
Foshan Aqua Gel Biotech Co., Ltd. — FEI 3007222546
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 4, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Foshan (China)
Citations
| ID | CFR | Description |
|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |