Warning letter
Chalgren Enterprises, Inc.: warning letter of Sep 4, 2001
FDA warning letter UCM178753 · San Francisco District Office
Key facts
| Reference number | UCM178753 |
|---|---|
| Company | Chalgren Enterprises, Inc. |
| Subject | Quality System Regulations for Medical Devices/Electromyographic Electrodes/Adulterated |
| Issue date | Sep 4, 2001 |
| Posted date | Sep 4, 2001 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 820, 803 |
| Country | 3 |
| Inspection city | Gilroy |
| Inspection ZIP | 95020-3631 |
| Inspection start date | Aug 7, 2001 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- VAI 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: