FDA EIR - Avella of Deer Valley dba Avella Specialty Pharmacy - April 19, 2018

An unannounced FDA surveillance inspection of Avella Specialty Pharmacy (FEI: 3006345305) in Phoenix, AZ, occurred from April 10-19, 2018. Operating as a sterile drug product manufacturer under 21 CFR 211 and 503B outsourcing facility guidelines, the inspection focused on their Suite 16 site to ensure contamination controls and compliance.

The inspection identified three primary violations on Form FDA 483. First, the quality control unit failed to adequately qualify vendors and analytical service providers, and did not address audit deficiencies. Second, the firm used a sporicidal agent with a contact time shorter than recommended without proper qualification studies. Third, a repeat observation from 2015 noted that labels for several compounded drugs lacked the required "This is a compounded drug" statement and dosage form. Additional discussion items included incorrect product labeling, insufficient detail in smoke study records, inadequate sampling plans for endotoxin and potency testing, absence of a comprehensive stability program SOP, limited batch testing for Povidone Iodine stability, and unvalidated potency test methods by a contract laboratory.

Management at Avella Specialty Pharmacy was cooperative and committed to providing a written response to all observations within fifteen business days. The firm has a history of submitting bi-annual reports to the agency regarding corrective actions from previous inspections.