FDA 483 - Synergy Pharmacy Services, Inc. - June 21, 2016

The FDA Form 483 details significant deficiencies in aseptic processing and quality control at a facility producing sterile drug products, specifically Glutathione Sterile Inhalation solution.

Key violations include: - **Inadequate Media Fills:** Media fills used for technician qualification do not simulate current processes, lack challenging conditions, and deviate from Policy # RV-IV-18. Deficiencies include incorrect media fill process simulation, absence of growth promotion tests, undocumented incubator use, and lack of comprehensive media fill documentation. - **Contamination Control Issues:** Lab coats identified as single-use are re-used and received in non-sealed bags, indicating non-sterility. Sterile coveralls are not required or observed in the ISO 5 area. - **Insufficient Personnel Monitoring:** No documented fingertip sampling after media fills or production batches, and no procedure requiring it. - **Environmental Monitoring Deficiencies:** No continuous or periodical monitoring of air pressure differentials, relative humidity, or temperature during operations in ISO 5 and ISO 7 areas. Viable and non-viable monitoring is not performed or required in the ISO 5 area during production, nor is surface monitoring on the curtain between ISO 5 and 7 areas. Acceptance criteria are not justified. - **Air Supply and Filtration Issues:** Policy RX-IV-13 lacks acceptance criteria for ISO 5 and ISO 7 cleanroom certification, does not require review of contractor certification packages, or documentation of static/dynamic conditions.