Warning letter
Medefil Incorporated [ARCHIVED]: warning letter of Jun 10, 2010
FDA warning letter 97345 · Chicago District Office
Key facts
| Reference number | 97345 |
|---|---|
| Company | Medefil Incorporated [ARCHIVED] |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jun 10, 2010 |
| Posted date | Jun 10, 2010 |
| Issuing office | Chicago District Office |
| Product type | Devices |
| CFR sections cited | 600, 803, 803.17(a)(1), 803.17(b), 803.50(a)(1), 803.50(a)(2), 803.18, 820, 820.40, 803.50(b)(3) |
| Inspection city | Glendale Heights |
| Inspection ZIP | 60139 |
| Inspection start date | Dec 1, 2009 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: