Warning Letter to Meditech Laboratories Cites Significant Contamination Risk
Meditech Laboratories has received an FDA warning letter that raises serious concerns regarding practices at a compounding facility in Las Vegas.
The FDA noted serious deficiencies in production of sterile drug products, including inadequate contact time for the sporicidal agent used to disinfect aseptic processing areas.
The company also failed to demonstrate through appropriate studies that a hood is able to provide adequate protection of the ISO 5 area in which sterile products are processed.
The FDA said that as of March 5, Meditech had temporarily ceased compounding sterile products, and as of March 17 had voluntarily recalled certain products.