Warning letter
Zimmer Manufacturing B.V.: warning letter of Sep 19, 2012
FDA warning letter 348259 · San Juan District Office
Key facts
| Reference number | 348259 |
|---|---|
| Company | Zimmer Manufacturing B.V. |
| Subject | CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation |
| Issue date | Sep 19, 2012 |
| Posted date | Sep 19, 2012 |
| Issuing office | San Juan District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Mercedita |
| Inspection ZIP | 00715 |
| Inspection start date | Jun 5, 2012 |
| 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: