Warning letter
Spectronics Corporation: warning letter of May 19, 2005
FDA warning letter UCM075417 · New York District Office
Key facts
| Reference number | UCM075417 |
|---|---|
| Company | Spectronics Corporation |
| Subject | Quality System Regulation for Medical Devices/Adulterated |
| Issue date | May 19, 2005 |
| Posted date | May 19, 2005 |
| Issuing office | New York District Office |
| Product type | Devices |
| CFR sections cited | 820, 803.17, 803 |
| Country | 3 |
| Inspection city | Westbury |
| Inspection ZIP | 11590-1731 |
| Inspection start date | Apr 5, 2005 |
| 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: