FDA Slaps Texas Plant With Warning Letter Over GMP, Labeling Issues

March 14, 2016

A contract manufacturer is being hit with a warning letter over a slew of GMP and labeling violations.

The warning letter stems from a Jan. 12 to Feb. 13, 2015 inspection of Texas-based Chemolee Lab that turned up six significant violations at the facility, which produces OTC and finished products for other companies.

The first major complaint in the Feb. 23 letter, which was posted online last week, concerns Chemolee’s failure to investigate unexplained discrepancies in batch production or determine the specifications for any batch components it produces. This includes batches of acne cream that failed microbial tests and other, unspecified products that failed three different microbial tests.