FDA WARNING_LETTER - Advanced Physician Solutions, Inc. - January 16, 2015

On November 3, 2015, the FDA issued a Warning Letter to Advanced Physician Solutions, Inc., d/b/a Advanced Compounding Pharmacy, following an inspection from January 12-16, 2015. The inspection revealed the firm was producing drug products without valid prescriptions for individually-identified patients and had serious deficiencies in sterile drug production practices, posing patient risks.

Violations included an external air conditioning unit in the cleanroom without HEPA filter data or airflow assessment, an aseptic compounding sterilizer in unclassified air, and the use of non-sterile cleaning wipes on ISO 5 surfaces. The firm also failed to demonstrate adequate protection of the ISO 5 area.

These issues led to drugs being deemed unapproved new drugs, misbranded, and adulterated under the Federal Food, Drug, and Cosmetic Act (FDCA) sections 505(a), 502(f)(1), 501(a)(2)(A), and 501(a)(2)(B). Specific CGMP violations cited included failures in equipment maintenance for aseptic conditions, stability testing, preventing microbiological contamination, environmental monitoring, cleaning/disinfecting, and final product testing for sterility. The firm also compounded 17-hydroxyprogesterone caproate, appearing to be an essentially copied commercially available drug (Makena), which may not qualify for 503A exemptions.

The FDA acknowledged the