health solutions pharmacy center inc – FDA Warning Letter, Jan 28, 2019

The FDA issued a Warning Letter to Health Solutions Pharmacy Center, Inc. dba Professional Compounding Pharmacy following an inspection from December 10, 2018, to January 28, 2019. The inspection revealed that drug products failed to meet Section 503A of the FDCA conditions for exemption from certain provisions, specifically lacking valid prescriptions for individually-identified patients for products like oral gel, ophthalmic solution, and solution distributed between September 1, 2018, and December 10, 2018. This renders these "ineligible drug products" subject to FDA approval, adequate labeling, and CGMP requirements.

The letter cited serious deficiencies in sterile drug product practices, leading to adulterated products under Section 501(a)(2)(A) of the FDCA due to insanitary conditions. Violations included: water dripping from the ISO7 cleanroom ceiling, loose ceiling tiles, a household air freshener in an ISO5 workstation, use of non-pharmaceutical grade equipment and components (e.g., beakers, spatulas, non-sterile wipes, non-pharmaceutical grade water/alcohol), inadequate cleaning procedures (e.g., failure to routinely clean ISO5, not using sporicidal agents), lack of adequate airflow studies, no media fill studies, deficient personnel gowning and aseptic practices, and porous/particle-generating ISO5 workstation surfaces.

Furthermore, the