FDA Inspection 1141159 — Cosmax Nbt Usa, Inc.
The FDA completed an inspection of Cosmax Nbt Usa, Inc. on May 4, 2021 in Garland, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 4, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Garland, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15673 | 21 CFR 111.315(a) | Criteria for establishing specifications |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15886 | 21 CFR 111.77(b) | Specifications not met - identity; component, reject |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16038 | 21 CFR 111.605(b) | Records - original, true copies |
| 4464 | 21 CFR 108.25(c)(1) | Registration |