Warning letter
Laser Engineering, Inc.: warning letter of Sep 25, 2014
FDA warning letter 432044 · New Orleans District Office
Key facts
| Reference number | 432044 |
|---|---|
| Company | Laser Engineering, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Sep 25, 2014 |
| Posted date | Oct 13, 2014 |
| Issuing office | New Orleans District Office |
| Product type | Devices |
| CFR sections cited | 1040.10(h)(1)(i), 803, 803.50(a)(2), 820, 820.40, 1002.11, 1040.10(f)(2)(i), 1040.10 |
| Inspection city | Nashville |
| Inspection ZIP | 37211 |
| Inspection start date | Mar 26, 2014 |
| 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: