FDA Inspection 1075922 — Bora Pharmaceuticals Inc.
The FDA completed an inspection of Bora Pharmaceuticals Inc. on Dec 19, 2018 in Maple Grove, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 19, 2018
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Maple Grove, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |