Warning letter
Elkhart Pharmacy: warning letter of May 8, 2017
FDA warning letter 508507 · Dallas District Office
Key facts
| Reference number | 508507 |
|---|---|
| Company | Elkhart Pharmacy |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | May 8, 2017 |
| Posted date | May 16, 2017 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 211.28(a), 210.1(b), 211.42(c)(10)(v), 200.10(b) |
| Inspection city | Elkhart |
| Inspection ZIP | 75839 |
| Inspection start date | Dec 14, 2015 |
| 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: