FDA Inspection 917115 — Consolidated Chemical, Inc
The FDA completed an inspection of Consolidated Chemical, Inc on March 24, 2015 in Saint Louis, MO. 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
- March 24, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4415 | 21 CFR 211.204 | Returned drug products with doubt cast as to safety et. al. |