Epimed International, Inc
Form 483 issued July 12, 2016 · Johnstown, New York
- Inspection
- May 26 – Jul 12, 2016
- Investigator
- Scott R. Izyk
- Observations
- 13
- Pages
- 12
- FEI number
- 1316297
In short: On July 12, 2016, FDA issued a Form 483 with 13 observations to Epimed International, Inc in Johnstown, New York (FEI 1316297) after an inspection that ran May 26 – Jul 12, 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
CAPA and design controls account for 9 of 13 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Procedures for design validation have…
- 03
Procedures for design transfer have…
- 04
The type and extent of control to be exercised over the product, services and suppliers…
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 firmEpimed International, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Epimed International, Inc?
FDA listed 13 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 Epimed International, Inc?
Scott R. Izyk is named on this Form 483, for the inspection of May 26 – Jul 12, 2016. Each investigator has a profile showing what they cite most.
When was Epimed International, Inc inspected by FDA?
The inspection ran May 26 – Jul 12, 2016, and the Form 483 is dated July 12, 2016.
How do I get the full Form 483 for Epimed International, 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.