FDA Inspection 1248502 — Cosmax Bio, Inc.
The FDA completed an inspection of Cosmax Bio, Inc. on August 30, 2024 in Jecheon. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 30, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Jecheon (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |
| 22818 | 21 CFR 111.10(b) | Hygienic practices |
| 22836 | 21 CFR 111.27(a) | Equipment - design - appropriate and suitable |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22897 | 21 CFR 111.325(b) | Make and keep records - laboratory operations |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 3086 | 21 CFR 114.100(b) | Maintenance of processing and production records |