John W Hollis Inc – FDA Warning Letter, Mar 21, 2014

An FDA inspection of John Hollis Pharmacy (Feb-Mar 2014) identified serious violations in drug compounding. The firm produced drugs without valid individual patient prescriptions, making them unapproved new drugs (FDCA 505(a)) and misbranded (FDCA 502(f)(1)). Sterile drug products were prepared under insanitary conditions, leading to adulteration (FDCA 501(a)(2)(A)). Deficiencies included inadequate facility design (ISO 5 hood in unclassified area, poor air control/separation), insufficient environmental/personnel monitoring, unacceptable material handling (bare hands, no disinfection), and poor aseptic technique (no hand washing, touching non-sterile surfaces). Significant CGMP violations (FDCA 501(a)(2)(B)) were also cited for non-prescription drugs. These encompassed failures in aseptic area air supply (21 CFR 211.42(c)(10)(iii)), cleaning/disinfection (21 CFR 211.42(c)(10)(v)), stability testing (21 CFR 211.166(a)), microbiological contamination prevention procedures (21 CFR 211.113(b)), environmental monitoring (21 CFR 211.42(c)(10)(iv)), final product conformance testing (21 CFR 211.167(a)), and personnel clothing (21 CFR 211.28(a)). The firm ceased office use compounding, committed to individual prescriptions, recalled sterile products, and halted aseptic operations. FDA recommends a comprehensive third-party assessment if sterile production resumes, demanding correction of all insanitary conditions and full CGMP compliance. Failure to correct violations may lead to legal action. A written response detailing corrective actions is required within 15 working days.