FDA 483 - ImprimisRx CA, Inc., dba ImprimisRx - March 14, 2016

This FDA Form 483 document details observations from an inspection, indicating several deficiencies in a drug manufacturing facility. Key issues include inadequate validation of sterilization processes, leading to potential microbiological contamination of sterile drug products. Personnel clothing was deemed inappropriate for their duties, and the system for monitoring environmental conditions in aseptic processing areas was deficient.

The facility's quality control unit lacked written responsibilities and procedures, and existing ones were not fully followed. Deficiencies were also noted in the cleaning and disinfecting procedures for aseptic processing rooms and equipment. Furthermore, drug product containers and closures were not handled and stored to prevent contamination, and the buildings were not maintained in a clean and sanitary condition. Finally, routine equipment calibration was not performed according to a written program, raising concerns about equipment performance and product quality. These observations highlight significant gaps in quality control, aseptic processing, and facility maintenance.