FDA Inspection 1205692 — Continental Manufacturing Chemist
The FDA completed an inspection of Continental Manufacturing Chemist on May 10, 2023 in Huxley, IA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- May 10, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Huxley, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |