FDA Intel

Claremore Compounding Center

FDA inspection history across 2 sites, 2020

1
Warning letter
1
Form 483

Every document, by year

  • Warning letter
  • Form 483

2020: one warning letter and one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2020One warning letter and one Form 483, at Oklahoma and Claremore, Oklahoma.

Cited most

Across all Claremore Compounding Center observations on file

The complete Claremore Compounding Center 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
2020-08-21Warning letter Warning letter$99
2020-01-24483 Form 483$99

Investigators on these documents

Margaret M. Annes (1)

FEI number 3004549371 · most recent document Aug 21, 2020

About Claremore Compounding Center

How many FDA Form 483s has Claremore Compounding Center received?

FDA Intel has 1 Form 483 on file for Claremore Compounding Center; the most recent is dated Jan 24, 2020.

When was Claremore Compounding Center last inspected by FDA?

The most recent FDA inspection document on file for Claremore Compounding Center is a Form 483 dated Jan 24, 2020, for the site in Claremore, Oklahoma.

What did FDA cite at Claremore Compounding Center?

The regulations cited most in the observations on file for Claremore Compounding Center are 21 CFR 211.165(a) (Testing and release for distribution), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time; FDCA 501(a)(2)(A) (Insanitary conditions), 1 time.

Has Claremore Compounding Center received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for Claremore Compounding Center; the most recent is dated Aug 21, 2020.

Claremore Compounding Center FDA Inspection History & 483s · FDA Intel