Electro Cap International Inc.
Form 483 issued January 23, 2015 · Eaton, Ohio
- Inspection
- Jan 13 – Jan 23, 2015
- Investigators
- Philip S. Woodward· Teresa K. Kastner
- Observations
- 6
- Pages
- 6
- FEI number
- 1000119368
In short: On January 23, 2015, FDA issued a Form 483 with 6 observations to Electro Cap International Inc. in Eaton, Ohio (FEI 1000119368) after an inspection that ran Jan 13 – Jan 23, 2015. The investigators were Philip S. Woodward and Teresa K. Kastner. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
- 02
Procedures for design change have…
- 03
Procedures for finished device acceptance have…
- 04
There is no agreement with suppliers to notify you of changes in…
This inspection in context
Philip S. Woodward
1 document · 2015
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Ohio.
The firmElectro Cap 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 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Electro Cap International Inc.?
FDA listed 6 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The opening words of each observation are shown on this page.
Who inspected Electro Cap International Inc.?
Philip S. Woodward and Teresa K. Kastner are named on this Form 483, for the inspection of Jan 13 – Jan 23, 2015. Each investigator has a profile showing what they cite most.
When was Electro Cap International Inc. inspected by FDA?
The inspection ran Jan 13 – Jan 23, 2015, and the Form 483 is dated January 23, 2015.
How do I get the full Form 483 for Electro Cap 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.