FDA Inspection 822708 — Continental Manufacturing Chemist, Inc.
The FDA completed an inspection of Continental Manufacturing Chemist, Inc. on Mar 15, 2013 in Madrid, IA. 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). 14 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 15, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Madrid, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1504 | 21 CFR 211.122(d) | Labels and labeling stored separately |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |