FDA WARNING_LETTER - Ionia Pharmacy - March 06, 2015

On December 22, 2015, the FDA issued a Warning Letter to Ionia Pharmacy, LLC, following an inspection from March 3-6, 2015, prompted by an adverse event report. The inspection revealed the firm was producing drug products without valid prescriptions for individually-identified patients and exhibited serious deficiencies in sterile drug production practices, posing patient risks.

Key violations included: - **Lack of Valid Prescriptions:** A portion of compounded drugs lacked individual patient prescriptions, rendering them unapproved new drugs and misbranded under FDCA Sections 505(a) and 502(f)(1). - **Insanitary Conditions:** Sterile products were prepared under insanitary conditions, making them adulterated per FDCA Section 501(a)(2)(A). Deficiencies included improper environmental sampling, lack of pressure differential monitoring, use of non-sterile wipes and materials in ISO 5 areas, inadequate disinfection of items, exposed operator skin/eyes, and unvalidated hood protection. - **CGMP Violations:** For drugs produced without individual prescriptions, significant Current Good Manufacturing Practice (CGMP) violations were observed, leading to adulteration under FDCA Section 501(a)(2)(B). Specific violations cited 21 CFR Part 211, including inadequate environmental monitoring (211.42(c)(10)(iv)), lack of validated aseptic procedures (21