FDA Inspection 1076468 — Nnodum Pharmaceuticals
The FDA completed an inspection of Nnodum Pharmaceuticals on December 20, 2018 in Cincinnati, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 20, 2018
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Cincinnati, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15562 | 21 CFR 111.260(l)(1) | Batch record - quality control review; production |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15894 | 21 CFR 111.80(d) | Specifications - representative samples; unique lot |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |