FDA Intel

Epimed International, Inc

FDA inspection history across 2 sites, 2012 to 2016

1
Form 483
1
Warning letter

Every document, by year

  • Form 483
  • Warning letter

2012: one warning letter; 2016: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2012One warning letter, at Irving, Texas.
  2. 2016One Form 483, at Johnstown, New York.

Cited most

Across all Epimed International observations on file

  • 21 CFR 820.30(b)
    Design controls
    4
  • 21 CFR 803.17
    What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
    1
  • 21 CFR 803.56
    If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?
    1
  • 21 CFR 820.100(a)
    Corrective and preventive action
    1
  • 21 CFR 820.181
    Device master record
    1

The complete Epimed International file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Documents

2 on file, newest first
DateDocumentPrice
2016-07-12483 Form 483$99
2012-09-19Warning letter Warning letter$99

Investigators on these documents

Scott R. Izyk (1)

FEI number 1316297 · most recent document Jul 12, 2016

About Epimed International, Inc

How many FDA Form 483s has Epimed International, Inc received?

FDA Intel has 1 Form 483 on file for Epimed International, Inc; the most recent is dated Jul 12, 2016.

When was Epimed International, Inc last inspected by FDA?

The most recent FDA inspection document on file for Epimed International, Inc is a Form 483 dated Jul 12, 2016, for the site in Johnstown, New York.

What did FDA cite at Epimed International, Inc?

The regulations cited most in the observations on file for Epimed International, Inc are 21 CFR 820.30(b) (Design controls), 4 times; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 803.56 (If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?), 1 time.

Has Epimed International, Inc received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for Epimed International, Inc; the most recent is dated Sep 19, 2012.