Warning letter
Lee Medical International, Inc.: warning letter of Jun 23, 2005
FDA warning letter UCM075457 · New Orleans District Office
Key facts
| Reference number | UCM075457 |
|---|---|
| Company | Lee Medical International, Inc. |
| Subject | CGMP for Medical Devices/QSR/Adulterated/Misbranded |
| Issue date | Jun 23, 2005 |
| Posted date | Jun 23, 2005 |
| Issuing office | New Orleans District Office |
| Product type | Devices |
| CFR sections cited | 820, 20.20, 20.120, 803, 803.17, 803.18(a), 803.50(a)(2), 803.50(b)(2), 820.40 |
| Country | 3 |
| Inspection city | Harahan |
| Inspection ZIP | 70123-3206 |
| Inspection start date | Feb 3, 2005 |
| 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: