Warning letter
Engler Engineering Corporation: warning letter of Jul 20, 2001
FDA warning letter UCM178482 · Florida District Office
Key facts
| Reference number | UCM178482 |
|---|---|
| Company | Engler Engineering Corporation |
| Subject | Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Jul 20, 2001 |
| Posted date | Jul 20, 2001 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 872.4200, 820, 820.40 |
| Country | 3 |
| Inspection city | Hialeah |
| Inspection ZIP | 33013-2139 |
| Inspection start date | May 15, 2001 |
| 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: