FDA Inspection 1013358 — Continental Manufacturing Chemist, Inc.
The FDA completed an inspection of Continental Manufacturing Chemist, Inc. on April 28, 2017 in Madrid, IA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 28, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Madrid, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |