Warning letter
AGFA healthcare Corp. [ARCHIVED]: warning letter of Apr 15, 2011
FDA warning letter 162752 · New England District Office
Key facts
| Reference number | 162752 |
|---|---|
| Company | AGFA healthcare Corp. [ARCHIVED] |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Apr 15, 2011 |
| Posted date | Apr 15, 2011 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 806, 806.20, 803.50(b)(1), 803.52(b)(2), 803.52(f)(1), 806.2(j), 820, 806.10(b) |
| Inspection city | Canton |
| Inspection ZIP | 02021 |
| Inspection start date | Nov 30, 2010 |
| 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: