avella of deer valley, inc. – FDA Warning Letter, Feb 25, 2013

On January 17, 2014, the FDA issued a Warning Letter to Avella of Deer Valley, Inc., following an inspection from February 19-25, 2013. The inspection revealed that the company was producing drug products without valid prescriptions for individually-identified patients for a significant number of items. Furthermore, serious deficiencies were observed in their sterile drug product manufacturing practices, including technicians performing aseptic operations while wearing non-sterile gowns and with exposed skin. These issues were noted on a Form FDA 483.

The FDA determined that drugs compounded without valid prescriptions are not exempt under FDCA section 503A and are considered unapproved new drugs and misbranded drugs, violating sections 505(a) and 502(f)(1) of the FDCA. Additionally, sterile products were deemed adulterated under section 501(a)(2)(A) due to insanitary conditions. The company's manufacturing of drugs without individual prescriptions also subjected them to Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), which were violated. Specific CGMP violations included failure to establish procedures to prevent microbiological contamination (21 CFR 211.113(b)), ensure appropriate personnel clothing (21 CFR 211.28(a)), and monitor environmental conditions in aseptic areas (21 CFR 21