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In Brief: Tri-Med Labs

This article was originally published in The Tan Sheet

Executive Summary

Tri-Med Labs: "Serious" deviations from GMP regs were documented by FDA investigators at Tri-Med's Somerset, N.J. facility, FDA says in a March 26 warning letter. The letter cites various problems in the firm's manufacture, processing, packing and holding of various drug products, causing the products to be considered adulterated under the FD&C Act. For example, Tri-vitamin Drops with Fluoride .25 mg Supplement for Infants contains levels of vitamins A and D and ascorbic acid exceeding the label claims...

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