Warning letter
Genesis BPS, LLC.: warning letter of Jun 12, 2013
FDA warning letter 396662 · New Jersey District Office
Key facts
| Reference number | 396662 |
|---|---|
| Company | Genesis BPS, LLC. |
| Subject | Premarket Approval/Misbranded/Adulterated |
| Issue date | Jun 12, 2013 |
| Posted date | Jun 12, 2013 |
| Issuing office | New Jersey District Office |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3)(i), 807.81(b) |
| Inspection city | Mahwah |
| Inspection ZIP | 07430 |
| Inspection start date | Feb 4, 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: