FDA 483 - Empower Pharmacy - March 06, 2020

The FDA inspection identified several deficiencies at the facility. Aseptic processing areas lacked adequate environmental monitoring, as procedure T06.04, Revision 02, required documentation of differential pressure, relative humidity, and temperature before and during sterile drug production, but these results were not consistently recorded in batch records from 2/4/2019 to 2/28/2020. Time limits for production phases were not established to ensure drug product quality.

The quality control unit's responsibilities and procedures were not fully followed. Specifically, the firm failed to adequately implement change control procedure T01.05, Revision 03, for changes to approved protocols. Examples include unapproved revisions to the protocol reporting sections of the (b)(4) Vial Washer Performance Qualification Report (Version V 3.0, 6/27/2019) and the (b)(4) (b)(4) Performance Qualification Report (Asset #(b)(4), Revision V.3, November 2019). Additionally, the firm did not adequately implement investigation procedure T08.19, Revision 03, as evidenced by unapproved changes to the (b)(4) (b)(4) Performance Qualification Protocol (Asset #(b)(4), Revision V.3, November 2019) resulting from investigations.

The facility compounded drug products essentially copied from approved drugs not on the drug shortage