FDA WARNING_LETTER - Zions Rx Formulations Services LLC dba Rx Formuations Serv. - January 09, 2014

The FDA issued a Warning Letter to Zion Rx Formulations Services, LLC, following an inspection from December 3, 2013, to January 9, 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 patient risks.

Key violations include: - **Contamination:** Nocardia, sp. was found in calcium gluconate 10% injection (lot #117466@8), and environmental samples tested positive for gram-negative bacteria and spore-forming microbes, including fungi. - **Aseptic Processing Deficiencies:** Operators processed sterile drugs with exposed facial skin; sporicidal agents were not used for cleaning; viable and non-viable monitoring was infrequent; pressure differentials were not monitored; and hood studies failed to demonstrate adequate ISO 5 protection. - **Misbranding and Adulteration:** Drugs compounded without individual patient prescriptions were deemed misbranded under FDCA Section 502(f)(1) and adulterated under Section 501(b). All sterile products were adulterated under Section 501(a)(2)(A) due to insanitary conditions. The contaminated calcium gluconate was also adulterated under Section 501(a)(1) and 501(b) for failing USP sterility standards. - **CGMP Violations:** The