FDA WARNING_LETTER - Home Intensive Care Pharmacy, Inc. - March 01, 2013

An FDA inspection of Home Intensive Care Pharmacy, LLC from February 25 to March 1, 2013, revealed significant violations, primarily the production of drug products without valid prescriptions for individually-identified patients. This practice means the drugs do not qualify for exemptions under FDCA Section 503A and are deemed misbranded under section 502(f)(1) due to inadequate directions for use. Furthermore, sterile drug products were prepared under insanitary conditions, such as porous particleboard workbenches and improper technician aseptic practices, rendering them adulterated under FDCA section 501(a)(2)(A). The firm also exhibited significant Current Good Manufacturing Practice (CGMP) violations, leading to adulterated drugs under section 501(a)(2)(B). Specific CGMP failures included inadequate personnel clothing (21 CFR 211.28(a)), insufficient equipment maintenance for aseptic conditions (21 CFR 211.42(c)(10)(vi)), lack of environmental monitoring (21 CFR 211.42(c)(10)(iv)), absence of appropriate written procedures for preventing microbiological contamination and process validation (21 CFR 211.113(b)), and inadequate cleaning/disinfecting systems (21 CFR 211.42(c)(10)(v)). The FDA requires prompt corrective actions, including a comprehensive assessment of manufacturing operations, possibly with a third-party consultant, and a written response within fifteen working days detailing corrective steps and recurrence prevention. Failure to comply may result in legal action, including seizure and injunction, and impact federal contracts.