In Brief: Accupack Midwest warning letter
This article was originally published in The Tan Sheet
Executive Summary
Accupack Midwest warning letter: FDA cites "serious deviations" from GMPs for Accupack's SPF-15 sunscreen lip balm in an April 23 warning letter. Among other deviations were sale and distribution of two batches "without appropriate laboratory testing, including tests for the identity and strength of each active ingredient," and failure to establish and maintain appropriate records. The company, which has manufactured the product for about six months, says it has contacted FDA and will be in compliance by June 17...
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Accupack Midwest warning letter: FDA cites "serious deviations" from GMPs for Accupack's SPF-15 sunscreen lip balm in an April 23 warning letter. Among other deviations were sale and distribution of two batches "without appropriate laboratory testing, including tests for the identity and strength of each active ingredient," and failure to establish and maintain appropriate records. The company, which has manufactured the product for about six months, says it has contacted FDA and will be in compliance by June 17.... |