Teva subsidiary Actavis Pharmaceuticals drew a warning letter from the FDA for laser-drilled tablet manufacturing at its Davie, Florida facility.
In a July 9-19, 2018, inspection of the facility, agency investigators found that the firm changed critical parameters for drilling operation in response to problems but failed to carry out an impact assessment or a change effectiveness verification.
The firm also failed to properly qualify operators to perform acceptable quality level inspections of its laser drilled products. The agency noted that only a single quality assurance inspector documented the inspection of tablets for the presence of laser drilled holes. The inspections are intended to catch undrilled tablets before a batch is released.