FDA Inspection 874461 — Acetar Bio-Tech Inc.
The FDA completed an inspection of Acetar Bio-Tech Inc. on March 24, 2014 in Xian. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Xian (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15669 | 21 CFR 111.310(c) | Laboratory facilities - dietary supplement specifications |
| 15718 | 21 CFR 111.375(a) | Records-manufacturing operation:originals,copies,electronic |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15978 | 21 CFR 111.123(a)(2) | Quality control operations - batch production records |