Electro Cap International Inc.
FDA inspection history in Eaton, Ohio, 2011 to 2015
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2011: one warning letter; 2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter, at Eaton, Ohio.
- 2015One Form 483, at Eaton, Ohio.
Cited most
Across all Electro Cap International observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.160(b)Distribution1
- 21 CFR 820.30(i)Design controls1
- 21 CFR 820.40Document controls1
- 21 CFR 820.50Purchasing controls1
The complete Electro Cap International file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Eaton, Ohio
One Form 483 and one warning letter · 2011 to 2015 · 6 observations
Latest: Form 483, Jan 23, 2015 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-01-23 | 483 Form 483 | Eaton, Ohio | 6 | $99 |
| 2011-07-20 | Warning letter Warning letter | Eaton, Ohio | — | $99 |
Investigators on these documents
FEI number 1000119368 · most recent document Jan 23, 2015
About Electro Cap International Inc.
How many FDA Form 483s has Electro Cap International Inc. received?
FDA Intel has 1 Form 483 on file for Electro Cap International Inc.; the most recent is dated Jan 23, 2015.
When was Electro Cap International Inc. last inspected by FDA?
The most recent FDA inspection document on file for Electro Cap International Inc. is a Form 483 dated Jan 23, 2015, for the site in Eaton, Ohio.
What did FDA cite at Electro Cap International Inc.?
The regulations cited most in the observations on file for Electro Cap International Inc. are 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.160(b) (Distribution), 1 time; 21 CFR 820.30(i) (Design controls), 1 time.
Has Electro Cap International Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Electro Cap International Inc.; the most recent is dated Jul 20, 2011.