Warning: Hawkins, Inc.

September 28, 2006
Pharmaceutical Technology Editors

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:

  • Failure to demonstrate adequacy of re-test dating for 155 APIs repackaged for use by compounding pharmacies;

  • Failure to include on the certificate of analysis the name and address of the laboratory that performed the analysis;

  • Failure to periodically validate the supplier's certificate of analysis;

  • Failure to audit contract laboratories performing acceptance analyses;

  • Failure to maintain written procedures describing the responsibilities of the quality control unit.

  • Failure to retain samples of each API processed in the facility.

  • Failure to document that air-handling filters are changed according to standard operating procedures.

(The Warning did not include CFR section numbers with individual citations.)

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