Warning letter
Philips Medical Systems (Cleveland) Inc [ARCHIVED]: warning letter of Jun 7, 2011
FDA warning letter 158993 · Cincinnati District Office
Key facts
| Reference number | 158993 |
|---|---|
| Company | Philips Medical Systems (Cleveland) Inc [ARCHIVED] |
| Subject | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| Issue date | Jun 7, 2011 |
| Posted date | Jun 7, 2011 |
| Issuing office | Cincinnati District Office |
| Product type | Devices |
| CFR sections cited | 803.50(a)(2), 806.10(b), 820.40, 820, 806, 806.20, 803 |
| Inspection city | Cleveland |
| Inspection ZIP | 44143 |
| Inspection start date | Aug 25, 2010 |
| 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: