hhcs pharmacy, inc., – FDA Warning Letter, Jul 28, 2014

On May 14, 2015, the FDA issued a Warning Letter to HHCS Pharmacy, Inc., dba Freedom Pharmacy, following an inspection from July 14-28, 2014. The inspection revealed the firm was producing drug products without valid prescriptions for individually-identified patients and had serious deficiencies in sterile drug product manufacturing, posing contamination risks.

Violations included unsealed ceiling tiles in ISO 7 and 8 areas, inadequate monitoring of air pressure differentials, infrequent environmental monitoring in ISO 5 areas, and infrequent personnel monitoring. The firm also failed to use a sporicidal cleaning agent for ISO 5 laminar airflow workstations and could not demonstrate adequate protection from hoods in ISO 5 areas.

These issues led to charges of misbranded drugs under FDCA Section 502(f)(1) and adulterated drugs under Sections 501(a)(2)(A) and 501(a)(2)(B). The firm's compounded drugs, produced without individual prescriptions, are not exempt under Section 503A and are subject to CGMP regulations (21 CFR Parts 210 and 211). Specific CGMP violations included failure to establish procedures to prevent microbiological contamination (21 CFR 211.113(b)), inadequate cleaning/disinfecting systems (21 CFR 211.42(c)(10)(v)),