Warning letter
Consolidated Machine Corporation: warning letter of Sep 24, 2003
FDA warning letter UCM147735 · New England District Office
Key facts
| Reference number | UCM147735 |
|---|---|
| Company | Consolidated Machine Corporation |
| Subject | Lacks Premarket Approval, Investigational Device Exemption/QSR/Misbranded/Adulterated |
| Issue date | Sep 24, 2003 |
| Posted date | Sep 24, 2003 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 803, 807.81(a)(3)(i), 820 |
| Country | 3 |
| Inspection city | Billerica |
| Inspection ZIP | 01821-5735 |
| Inspection start date | May 29, 2003 |
| 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: