Warning letter
Gold Standard Diagnostics: warning letter of Apr 25, 2014
FDA warning letter 419704 · San Francisco District Office
Key facts
| Reference number | 419704 |
|---|---|
| Company | Gold Standard Diagnostics |
| Subject | Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Apr 25, 2014 |
| Posted date | Apr 25, 2014 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17, 820, 803.50(a), 803.50(b), 807.81(b) |
| Inspection city | Davis |
| Inspection ZIP | 95618 |
| Inspection start date | Nov 19, 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: