Warning letter
Calvin Scott & Company, Inc.: warning letter of Aug 25, 2020
FDA warning letter 606987 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 606987 |
|---|---|
| Company | Calvin Scott & Company, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Aug 25, 2020 |
| Posted date | Sep 8, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 210, 211.34, 211.22(a), 211.67(b), 211.137(a) |
| Inspection city | Albuquerque |
| Inspection ZIP | 87123 |
| Inspection start date | Mar 9, 2020 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: