US CMO Deltex Pharmaceuticals has been ordered to permanently halt manufacturing operations and recall all drugs it has distributed since October 2008, under a consent decree obtained by the FDA.
The injunction follows the observation of numerous violations from current good manufacturing practise (cGMP standards at Deltex’ 8,000 sqft manufacturing and packaging plant in Rosenburg, Texas during an inspection in 2008 .
These observations ranged from the failure to establish quality control procedures to concerns about how the contract manufacturing organisation (CMO) tested the active pharmaceutical ingredients (API) used in production.
The US Food and Drug Administration (FDA) also said that Deltex had been making several unapproved drug products, including Tannate Pediatric Suspension, DuohistTM DH Liquid, Ed-A-Hist DM and Bromphenex DM
Deltex, whose president Kabir Ahmed and vice president Mohidur Khan have also been barred from making or distributing drugs until the FDA’s observations have been addressed, has not yet commented on the consent decree.