FDA Warns Lex Pharmaceutical for cGMP Violations

Drugmaker Lex Pharmaceutical has been issued a warning letter following an FDA inspection that revealed a slew of manufacturing violations at the company's Medley, Fla., plant.

The warning letter documented 12 violations of current good manufacturing practice standards, as well as infractions for marketing new OTC drug products without approved new drug applications. The violations were discovered during a June 28 July 8, 2004, inspection of the Medley plant, where Lex manufactures OTC and prescription drugs.

Lex officials were unable to provide comment on the letter before press time.

To view the warning letter, go to http://www.fda.gov/foi/warning_letters/g5151d.pdf (http://www.fda.gov/foi/warning_letters/g5151d.pdf).