Warning letter
Spartan Chemical Company, Inc.: warning letter of Dec 15, 2021
FDA warning letter 614450 · Division of Pharmaceutical Quality Operations III
Key facts
| Reference number | 614450 |
|---|---|
| Company | Spartan Chemical Company, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 15, 2021 |
| Posted date | Dec 28, 2021 |
| Issuing office | Division of Pharmaceutical Quality Operations III |
| Product type | Drugs |
| CFR sections cited | 201.128, 207, 211.22, 211.34, 211.192, 330, 211.100(a) |
| Inspection city | Maumee |
| Inspection ZIP | 43537 |
| Inspection start date | Mar 1, 2021 |
| 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: