FDA Inspection 998475 — Accolade Pharma USA Inc.
The FDA completed an inspection of Accolade Pharma USA Inc. on December 29, 2016 in City Of Industry, CA. 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: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 29, 2016
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- City Of Industry, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 15985 | 21 CFR 111.123(b)(1) | Quality control - components, identity specifications |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |