FDA Inspection 954864 — Kingdomway Health Sciences LLC
The FDA completed an inspection of Kingdomway Health Sciences LLC on December 11, 2015 in Casa Grande, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 11, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Casa Grande, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |