FDA Inspection 1079075 — Chemco Corporation
The FDA completed an inspection of Chemco Corporation on February 12, 2019 in Miami Lakes, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 12, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami Lakes, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 4366 | 21 CFR 211.188(a) | Accurate reproduction included |
| 4386 | 21 CFR 211.198(b) | Written complaint record to be maintained at facility |
| 4576 | 21 CFR 211.192 | No written record of investigation |