North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Warning LetterOpen

Mr. Justin K. Graves Vice President North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding 1736 North Greenville Avenue Richardson , TX 75081-1808 United StatesFEI 3014229024Issued Nov 18, 2022Division of Pharmaceutical Quality Operations II

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3014229024.

Violations5

Issue DateNov 18, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Location: Mr. Justin K. Graves Vice President North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding 1736 North Greenville Avenue Richardson , TX 75081-1808 United States
FEI Number: 3014229024
Country: United States
Issue Date: November 18, 2022
Issuing Office: Division of Pharmaceutical Quality Operations II
Product Type: Drugs
Status: Open

Summary

North American Custom Laboratories, operating as FarmaKeio Superior Custom Compounding, was cited for producing sterile drug products under insanitary conditions that violated current good manufacturing practice requirements and rendered the drugs adulterated under federal law. An FDA inspection from March 1-10, 2022 identified serious deficiencies in the company's sterile drug production practices that put patients at risk, documented on an FDA Form 483. The company voluntarily recalled affected sterile drug products on April 5, 2022, following the inspection findings.

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding FDA Warning Letter, November 18, 2022