Warning letter
Forcemech International LLC: warning letter of Sep 21, 2022
FDA warning letter 634891 · Office of Medical Device and Radiological Health Division 3
Key facts
| Reference number | 634891 |
|---|---|
| Company | Forcemech International LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Sep 21, 2022 |
| Posted date | Oct 18, 2022 |
| Issuing office | Office of Medical Device and Radiological Health Division 3 |
| Product type | Devices |
| CFR sections cited | 801.3, 801, 820.40, 820, 801.20(a), 830.300(a), 830.60(a), 830.50(b), 830 |
| Inspection city | Pearland |
| Inspection ZIP | 77581 |
| Inspection start date | Mar 28, 2022 |
| Letter on fda.gov | fda.gov |
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: