GMP failures are one of two transgressions that have landed contract manufacturer Deltex Pharmaceuticals under a consent decree with the FDA. The agency charges distribution of unapproved and misbranded drugs, too.
Per the decree, Texas-based Deltex is recalling and destroying all the drugs it produced and distributed since October 2008.
A warning letter from that same year, which addresses eight GMP violations, figures prominently in the action. The FDA says that despite the company's acknowledgment of the manufacturing issues and promises to correct them, it has failed to comply. The agency says Deltex has "a history of significant violations of cGMP requirements."
Warning 2008-DAL-WL-03 cites a lack of controls that ensure drug identity, strength, quality and purity. Controls for component lot acceptance are similarly lacking. And Deltex failed to perform antimicrobial effectiveness testing on finished product formulations.
The consent decree names Deltex, company president Kabir Ahmed and VP Mohidur Khan. All are now prohibited from producing and distributing drugs.
- here's the FDA release
- read the article
- and see the 2008 warning letter