Custom RX, LLC

FDA inspection history in Wichita, Kansas, 2017 to 2018

1
Response
1
Form 483

Every document, by year

  • Response
  • Form 483

2017: one Form 483; 2018: one warning letter response.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2017–18One Form 483 and one warning letter response, at Wichita, Kansas.

Cited most

Across all Custom RX observations on file

The complete Custom RX file.

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

$298

The price of the documents, added to your cart together

Sites

Also: one document not tied to a site.

Documents

2 on file, newest first
DateDocumentPrice
2018-11-07Response Warning letter response$199
2017-08-15483 Form 483$99

Investigators on these documents

Rita K. Kabaso (1)

FEI number 3013444075 · most recent document Nov 7, 2018

About Custom RX, LLC

How many FDA Form 483s has Custom RX, LLC received?

FDA Intel has 1 Form 483 on file for Custom RX, LLC; the most recent is dated Aug 15, 2017.

When was Custom RX, LLC last inspected by FDA?

The most recent FDA inspection document on file for Custom RX, LLC is a Form 483 dated Aug 15, 2017, for the site in Wichita, Kansas.

What did FDA cite at Custom RX, LLC?

The regulations cited most in the observations on file for Custom RX, LLC are 21 CFR 211.113 (Control of microbiological contamination), 1 time.