Warning letter
Repro-Med Systems, Inc. d/b/a RMS Medical Products: warning letter of Feb 26, 2016
FDA warning letter 478416 · New York District Office
Key facts
| Reference number | 478416 |
|---|---|
| Company | Repro-Med Systems, Inc. d/b/a RMS Medical Products |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Feb 26, 2016 |
| Posted date | Mar 7, 2016 |
| Issuing office | New York District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17, 803.20, 807.81(a)(3)(i), 807.81(a)(3)(ii), 820, 803.50(a), 807.81(b) |
| Inspection city | Chester |
| Inspection ZIP | 10918 |
| Inspection start date | Jun 3, 2015 |
| 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: