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In Brief: Omega, Inc. warning letter

This article was originally published in The Tan Sheet

Executive Summary

Omega, Inc. warning letter: Carolina, Puerto Rico-based manufacturer receives April 9 FDA warning letter for GMP deviations in its manufacture of topical liquid drug products. The letter cites failures in Omega's manufacture of isopropyl rubbing alcohol 70% and hydrogen peroxide 3% topical solution as well a failure to include lot numbers for drug products intended for distribution. FDA acknowledges receipt of a March 18 letter concerning correction of the listed problems but notes that the company failed to fulfill an earlier commitment to address the same problems following a July 1994 inspection...





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