Warning letter
TALON, an S & S Technology Company: warning letter of Aug 2, 2019
FDA warning letter 580417 · Office of Medical Device and Radiological Health Operations, Division 3
Key facts
| Reference number | 580417 |
|---|---|
| Company | TALON, an S & S Technology Company |
| Subject | CGMP/QSR/Drug/Medical Devices/Adulterated |
| Issue date | Aug 2, 2019 |
| Posted date | Aug 13, 2019 |
| Issuing office | Office of Medical Device and Radiological Health Operations, Division 3 |
| Product type | Devices |
| CFR sections cited | 868.6100, 820, 820.40 |
| Inspection city | Houston |
| Inspection ZIP | 77095 |
| Inspection start date | Mar 11, 2019 |
| 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: