FDA Inspection 1217126 — Pharmaganics LLC
The FDA completed an inspection of Pharmaganics LLC on September 5, 2023 in Plymouth, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 5, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Plymouth, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15765 | 21 CFR 111.430(a) | Packaging, labeling operations:originals, copies, electronic |
| 15810 | 21 CFR 111.570(b)(2) | Record - product complaint; good manufacturing practice |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |