Warning letter
R&D; Engineering Of Earlham Inc: warning letter of May 16, 2014
FDA warning letter 429995 · Kansas City District Office
Key facts
| Reference number | 429995 |
|---|---|
| Company | R&D; Engineering Of Earlham Inc |
| Subject | Medical Device/CGMP/Adulterated |
| Issue date | May 16, 2014 |
| Posted date | Aug 5, 2014 |
| Issuing office | Kansas City District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Earlham |
| Inspection ZIP | 50072-1036 |
| Inspection start date | Apr 17, 2014 |
| 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: