The FDA fired a Form 483 at Lannett Company for quality control procedures and batch production and control record shortcomings.
The agency cited its Seymour, Indiana facility, which it inspected in February 2018, for failing to follow responsibilities and procedures for its quality control unit. The firm did not open investigations for all low level complains within their 45 day deadline as dictated by a standard operating procedure in place.
It also had deficient batch production and control records, as not all of them include documentation of the accomplishment of each step in packing. For example, its general packaging procedure stated that the number of desiccants needed per bottle on the start-up fill check sheet should be reported on its production batch record. However, it gave no reason as to why desiccant start-up checks are only documented if more than one bottle is required.
In addition, the investigator observed production personnel wiping and removing an insect from a raw material as the material was being threaded through an oven. The firm’s standard operating procedure — which requires the preservation of an area where a deviation or event occurs — was not followed in the observed situation.