Repro-Med Systems, Inc.
Form 483 issued December 16, 2016 · Chester, New York
- Inspection
- Nov 29 – Dec 16, 2016
- Investigator
- Scott R. Izyk
- Observations
- 8
- Pages
- 7
- FEI number
- 1318360
In short: On December 16, 2016, FDA issued a Form 483 with 8 observations to Repro-Med Systems, Inc. in Chester, New York (FEI 1318360) after an inspection that ran Nov 29 – Dec 16, 2016. The investigator was Scott R. Izyk. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
5 of 8 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A correction or removal, conducted to reduce a risk to health posed by a device, was…
- 02
Procedures for design change have…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Procedures have not been adequately established to control product that does not…
This inspection in context
Scott R. Izyk
5 documents · 2015–2016
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmRepro-Med Systems, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 806.10(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Repro-Med Systems, Inc.?
FDA listed 8 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Repro-Med Systems, Inc.?
Scott R. Izyk is named on this Form 483, for the inspection of Nov 29 – Dec 16, 2016. Each investigator has a profile showing what they cite most.
When was Repro-Med Systems, Inc. inspected by FDA?
The inspection ran Nov 29 – Dec 16, 2016, and the Form 483 is dated December 16, 2016.
How do I get the full Form 483 for Repro-Med Systems, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.