FDA Inspection 1149380 — CASAD Company Inc
The FDA completed an inspection of CASAD Company Inc on August 18, 2021 in Coldwater, OH. 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
- August 18, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Coldwater, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |