Warning letter
Foredom Electric Co.: warning letter of May 22, 2001
FDA warning letter UCM069703 · New England District Office
Key facts
| Reference number | UCM069703 |
|---|---|
| Company | Foredom Electric Co. |
| Subject | Quality System Regulation for Medical Device/Model 973 Powered Percussor |
| Issue date | May 22, 2001 |
| Posted date | May 22, 2001 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 820, 890.5660, 801.15, 801.109, 868.5665, 801.109(a)(2), 801.109(b), 801.109(c) |
| Country | 3 |
| Inspection city | Bethel |
| Inspection ZIP | 06801-1031 |
| Inspection start date | Jan 4, 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: