Warning letter
Greer Laboratories Inc: warning letter of Apr 21, 2014
FDA warning letter 417852 · Office of Regulatory Affairs
Key facts
| Reference number | 417852 |
|---|---|
| Company | Greer Laboratories Inc |
| Subject | CGMP Deviations |
| Issue date | Apr 21, 2014 |
| Posted date | May 6, 2014 |
| Issuing office | Office of Regulatory Affairs |
| Product type | Biologics |
| CFR sections cited | 211.110(a), 610.17, 211.56, 211.192, 211.42(c)(10)(iv), 211.84(d)(3), 211.94(a) |
| Inspection city | Lenoir |
| Inspection ZIP | 28645-3646 |
| Inspection start date | Nov 5, 2013 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- ADC 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: