FDA Inspection 1149902 — Accolade Pharma USA Inc.
The FDA completed an inspection of Accolade Pharma USA Inc. on August 26, 2021 in City Of Industry, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 26, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- City Of Industry, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |