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In Brief: Accupack Midwest Warning Letter

This article was originally published in The Rose Sheet

Executive Summary

Accupack Midwest Warning Letter: FDA cited "serious deviations" from GMPs for Accupack's SPF 15 lip balm in an April 23 warning letter. Among other deviations were the 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 full-scale for about six months, said it has been in contact with FDA and will be in compliance by June 17...
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