FDA Inspection 1112349 — NutraCap Holdings LLC
The FDA completed an inspection of NutraCap Holdings LLC on December 11, 2019 in Norcross, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 11, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Norcross, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15652 | 21 CFR 111.465(b) | Retain reserve samples - 1 year, 2 years |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15771 | 21 CFR 111.415(h) | Obsolete labels, packaging - dispose |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15911 | 21 CFR 111.90(b)(1) | In-process adjustment, component - no material review |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 16047 | 21 CFR 111.510 | Returned dietary supplement - material review, disposition |