McConnell Labs Inc.

Warning LetterOpen

Mr. Jim McConnell President McConnell Labs Inc. 406 SW Umatilla Ave. Redmond , OR 97756 United StatesFEI 3010298400Issued Oct 18, 2022Division of Pharmaceutical Quality Operations IV

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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 3010298400.

Violations4

Issue DateOct 18, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: McConnell Labs Inc.
Location: Mr. Jim McConnell President McConnell Labs Inc. 406 SW Umatilla Ave. Redmond , OR 97756 United States
FEI Number: 3010298400
Country: United States
Issue Date: October 18, 2022
Issuing Office: Division of Pharmaceutical Quality Operations IV
Product Type: Drugs
Status: Open

Summary

McConnell Labs Inc., an OTC drug manufacturer, failed to comply with current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated hand sanitizer products including Light Elegance Hand Sanitizer. The company did not conduct adequate identity testing on incoming raw materials such as active ingredients, ethanol, and isopropyl alcohol, instead relying solely on suppliers' Certificates of Analysis, one of which explicitly stated the ethanol was not intended for use in drug manufacturing. This violation of 21 CFR 211.84(d)(1) represented a significant breakdown in the firm's component verification controls required for pharmaceutical manufacturing.

McConnell Labs Inc. FDA Warning Letter, October 18, 2022