FDA Inspection 956318 — Foshan Aqua Gel Biotech Co., Ltd.
The FDA completed an inspection of Foshan Aqua Gel Biotech Co., Ltd. on December 4, 2015 in Foshan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
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 |