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ePT--the Electronic Newsletter of Pharmaceutical Technology
FDA issued a Warning Letter from its Minneapolis District Office to Hawkins, Inc., part of a diversified chemical company and pharmaceutical repackager here.
Minneapolis, MN (Sept. 26)-United States Food and Drug Administration issued a Warning Letter (http://www.fda.gov/foi/warning_letters/g6022d.htm) from its Minneapolis District Office to Hawkins, Inc. (www.hawkinschemical.com), part of a diversified chemical company and pharmaceutical repackager here. The five-page warning, issued Sept. 8 and posted Sept. 26, cites the company for seven deviations from current good manufacturing process in the repackaging and relabeling of active pharmaceutical ingredients from outside suppliers.
The listed shortcomings include:
(The Warning did not include CFR section numbers with individual citations.)