Mr. Andrew Schreyer
Senior Vice President
Mohawk Laboratories Division of NCH Corporation
2730 Carl Road
Irving , TX 75062
United StatesFEI 1610021Issued Jan 18, 2023Division of Pharmaceutical Quality Operations II
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 1610021.
Violations2
Issue DateJan 18, 2023
Product TypeDrugs
StatusOpen
Letter Details
Firm
Mohawk Laboratories Division of NCH Corporation
Location
Mr. Andrew Schreyer
Senior Vice President
Mohawk Laboratories Division of NCH Corporation
2730 Carl Road
Irving , TX 75062
United States
FEI Number
1610021
Country
United States
Issue Date
January 18, 2023
Issuing Office
Division of Pharmaceutical Quality Operations II
Product Type
Drugs
Status
Open
Summary
Mohawk Laboratories Division of NCH Corporation, a manufacturer of over-the-counter hand sanitizer products, was warned that its consumer hand sanitizer drug products were adulterated due to contamination with unacceptable levels of acetaldehyde and acetal impurities. FDA laboratory testing of three product lots, along with impurity test results from additional lots provided by the firm, demonstrated that the facility's quality assurance and manufacturing controls did not conform to Current Good Manufacturing Practice (CGMP) requirements. The company had distributed these contaminated hand sanitizer products as recently as April 19, 2022, and had ceased operations by June 10, 2022.
Mohawk Laboratories Division of NCH Corporation FDA Warning Letter, January 18, 2023
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