Florida Drugmaker Called Out for Quality Issues
The FDA cited an Actavis Laboratories facility in Davie, Florida, over quality violations observed during a July inspection, including shortcomings with laser drilling procedures.
The firm’s quality unit didn’t properly oversee its operations, procedures and systems, the agency said in a Form 483. For example, it didn’t put in place adequate written control procedures for qualification, operation, oversight and change control of its laser drilling process and equipment used for drilling holes in tablets.
“The absence of a hole in the tablet will significantly change the dissolution profile and cause out of specification dissolution rates that could adversely impact the therapeutic effect of the drug product,” the agency said.