Health Innovations Pharmacy, Inc – FDA 483, Feb 27, 2015

This FDA Form 483 details significant deficiencies in aseptic processing, quality control, and manufacturing practices. The facility's environmental monitoring (EM) system is inadequate, lacking post-production or daily monitoring, and written procedures for frequency, sampling, and action limits. Personnel monitoring is not performed, and no written procedures exist. Magnehelic gauges are absent, preventing positive pressure maintenance between the cleanroom and anteroom.

Cleaning and disinfection of equipment are deficient; cleaning of the ISO 5 hood and cleanroom/anteroom is undocumented, and appropriate methods/sporicidal agents cannot be verified. Hold times for in-process materials for sterile drug products (e.g., 17-Hydroxyprogesterone, Trimix) are not established or supported by data.

Sterilization processes lack validation. Cleaning agents and processes for depyrogenation are unqualified and unvalidated. Media fills are not performed semi-annually, preventing demonstration of sterile operations. Refrigerator temperature monitoring for sterile drug products is not real-time, and smoke studies for the ISO 5 hood are absent.

Finished sterile drug products are not tested for sterility or endotoxins. Incoming non-sterile components lack acceptance procedures and are not microbiologically tested. A written stability program for establishing Beyond Use Dates (BUDs) is absent, with BUDs assigned without justification (e.g., 6-month BUDs for Methylcobalamin and Trimix without preservatives).