CMP Industries, Lie
Form 483 issued May 29, 2015 · Albany, New York
- Inspection
- Apr 16 – May 29, 2015
- Investigator
- Scott R. Izyk
- Observations
- 4
- Pages
- 4
- FEI number
- 1315551
In short: On May 29, 2015, FDA issued a Form 483 with 4 observations to CMP Industries, Lie in Albany, New York (FEI 1315551) after an inspection that ran Apr 16 – May 29, 2015. The investigator was Scott R. Izyk. Most observations concern cAPA and design controls.
At a glance
CAPA and design controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
A correction or removal, conducted to reduce a risk to health posed by a device, was…
- 02
Procedures for corrective and preventive action have…
- 03
Procedures for design control…
- 04
Procedures for acceptance of incoming product have…
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 firmCMP Industries, Lie history
All 2 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 CMP Industries, Lie?
FDA listed 4 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected CMP Industries, Lie?
Scott R. Izyk is named on this Form 483, for the inspection of Apr 16 – May 29, 2015. Each investigator has a profile showing what they cite most.
When was CMP Industries, Lie inspected by FDA?
The inspection ran Apr 16 – May 29, 2015, and the Form 483 is dated May 29, 2015.
How do I get the full Form 483 for CMP Industries, Lie?
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.