Warning letter
Buderer Drug Company Inc: warning letter of Sep 20, 2016
FDA warning letter 506509 · Cincinnati District Office
Key facts
| Reference number | 506509 |
|---|---|
| Company | Buderer Drug Company Inc |
| Subject | Compounding Pharmacy/Adulteration/Misbranding |
| Issue date | Sep 20, 2016 |
| Posted date | Oct 25, 2016 |
| Issuing office | Cincinnati District Office |
| Product type | Drugs |
| CFR sections cited | 201.115, 211.42(c)(10)(iv), 211.94(c), 211.113(b), 211.167(a) |
| Inspection city | Perrysburg |
| Inspection ZIP | 43551 |
| Inspection start date | Dec 14, 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: