Warning letter
Transonic Systems Inc: warning letter of Jun 19, 2013
FDA warning letter 396350 · New York District Office
Key facts
| Reference number | 396350 |
|---|---|
| Company | Transonic Systems Inc |
| Subject | Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Jun 19, 2013 |
| Posted date | Jun 19, 2013 |
| Issuing office | New York District Office |
| Product type | Devices |
| CFR sections cited | 803.50(b), 820, 803.50(a), 803, 803.3, 803.17 |
| Inspection city | Ithaca |
| Inspection ZIP | 14850 |
| Inspection start date | Feb 25, 2013 |
| 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: