FDA Inspection 1111093 — Cosmax Nbt Usa, Inc.
The FDA completed an inspection of Cosmax Nbt Usa, Inc. on November 22, 2019 in Garland, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 22, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Garland, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15528 | 21 CFR 111.30(d) | Equipment - automated - controls, process changes |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15951 | 21 CFR 111.110(c) | Quality control operations - tests, examinations; results |
| 15954 | 21 CFR 111.113(a)(2) | Quality control master manufacturing record; material review, disposition |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |
| 16038 | 21 CFR 111.605(b) | Records - original, true copies |