Warning letter
Spoonamore Drug Co Inc: warning letter of Dec 18, 2015
FDA warning letter 455964 · Cincinnati District Office
Key facts
| Reference number | 455964 |
|---|---|
| Company | Spoonamore Drug Co Inc |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 18, 2015 |
| Posted date | Jan 11, 2016 |
| Issuing office | Cincinnati District Office |
| Product type | Drugs |
| CFR sections cited | 201.115, 211.166(a) |
| Inspection city | Louisville |
| Inspection ZIP | 40207 |
| Inspection start date | Jan 13, 2015 |
| Letter on fda.gov | web.archive.org |
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: