Warning letter
Orchid Orthopedic Solutions, LLC: warning letter of May 13, 2019
FDA warning letter 580112 · Center for Devices and Radiological Health
Key facts
| Reference number | 580112 |
|---|---|
| Company | Orchid Orthopedic Solutions, LLC |
| Subject | CGMP/QSR/Medical Devices/Adulterated, Orchid Orthopedic Solutions, LLC |
| Issue date | May 13, 2019 |
| Posted date | May 21, 2019 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Farmington Hills |
| Inspection ZIP | 48335 |
| Inspection start date | Feb 4, 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: