The FDA hit Noven Pharmaceuticals for noncompliances at its drug manufacturing facility in Miami, Florida.
The agency found the process qualification protocol for the firm’s transdermal product, Minivelle, lacked adequate data to support time-dependent manufacturing activities.
The facility’s program for evaluating quality attributes during in-process inspection failed to include examples of all potential critical or major defects necessary for a consistent and full inspection, the agency said in a Form 483 report. Critical defects for un-pouched units such as missing or incomplete adhesive were not recorded.
One of the company’s cleaning validation protocols for its Minivelle coating operation did not describe actions taken to ensure consistency in cleaning activities for stainless steel kettles used in manufacturing. For example, the protocol did not include clear labeling of sampling points selected to ensure the hardest to clean locations were sampled during the exercise.
A standard operating procedure describing general cleaning activities for production areas lacked complete and accurate documentation and the facility did not document that all cleaning steps were performed as required.
In addition, the firm’s retention sample program had no description of visual inspection steps to evaluate whether products conformed to specifications.