Inservco, Inc
Form 483 issued March 17, 2016 · Lagrange, Ohio
- Inspection
- Feb 29 – Mar 17, 2016
- Investigator
- Edward R. Kay
- Observations
- 6
- Pages
- 4
- FEI number
- 3010067461
In short: On March 17, 2016, FDA issued a Form 483 with 6 observations to Inservco, Inc in Lagrange, Ohio (FEI 3010067461) after an inspection that ran Feb 29 – Mar 17, 2016. The investigator was Edward R. Kay. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 4 of 6 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 that define the responsibility for review and the authority for the disposition of nonconforming product…
- 03
A device history record has…
- 04
Procedures for acceptance of incoming product have…
This inspection in context
Edward R. Kay
1 document · 2016
Cites 820.184 (device history record) more than any other section. Most of their documents are for sites in Ohio.
The firmInservco, Inc history
The site's inspection history, in date order.
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 Inservco, Inc?
FDA listed 6 observations on this Form 483, mostly about cAPA, production & process controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Inservco, Inc?
Edward R. Kay is named on this Form 483, for the inspection of Feb 29 – Mar 17, 2016. Each investigator has a profile showing what they cite most.
When was Inservco, Inc inspected by FDA?
The inspection ran Feb 29 – Mar 17, 2016, and the Form 483 is dated March 17, 2016.
How do I get the full Form 483 for Inservco, 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.