FDA Inspection 1120650 — Calvin Scott & Company, Inc.
The FDA completed an inspection of Calvin Scott & Company, Inc. on March 12, 2020 in Albuquerque, NM. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 12, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Albuquerque, NM (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1165 | 21 CFR 211.28(d) | Excluding Employees with Illness, Lesions |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1724 | 21 CFR 211.134(b) | Representative samples after completion |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |