The FDA issued a Form 483 to Noven Pharmaceuticals after observing numerous problems at the transdermal drug manufacturer’s Miami, Florida facility.
The agency found the process qualification protocol used with the firm’s transdermal product, Minivelle, did not include complete data to support time-dependent manufacturing activities. For certain samples, it lacked information required to justify their statistical significance.
The facility’s quality standards 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. Critical defects for un-pouched units, such as missing or incomplete adhesive, were not described in any record at the facility.