FDA WARNING_LETTER - Wedgewood Village Pharmacy, LLC - February 11, 2013

On February 21, 2014, the FDA issued a Warning Letter to Wedgewood Village Pharmacy, Inc. following an inspection from November 9, 2012, to February 11, 2013. The inspection revealed the firm was producing human drug products without valid prescriptions for individually-identified patients and exhibited serious deficiencies in sterile drug production, posing patient risks.

Violations included personnel in aseptic operations with exposed skin/hair, jewelry, gown holes, and in-ear headphones. Supplies and equipment were not routinely disinfected before entering ISO-5 areas, and gloved hands were not disinfected after handling non-sterile items. The firm also inadequately investigated multiple adverse event complaints, including lack of efficacy and injection site reactions.

The FDA determined that drugs compounded without individual patient prescriptions were unapproved new drugs and misbranded under FDCA sections 505(a) and 502(f)(1). Sterile products were adulterated under section 501(a)(2)(A) due to insanitary conditions. Additionally, the firm violated Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), leading to adulterated products under section 501(a)(2)(B). Specific CGMP violations included inadequate cleaning/disinfection systems, lack of final product testing for sterility, improper container closure processing, insufficient aseptic process validation, inappropriate