FDA 483 - Avella of Deer Valley dba Avella Specialty Pharmacy - April 19, 2018

During an inspection conducted from April 10 to April 19, 2018, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Avella of Deer Valley, operating as Avella Specialty Pharmacy, an outsourcing facility located in Phoenix, AZ. The inspection highlighted significant concerns related to the firm's quality control, aseptic processing, and drug product labeling, indicating a need for improved adherence to regulatory expectations.

Key observations included the company's failure to adequately qualify and re-qualify multiple critical vendors supplying drug components, container closures, and analytical testing services. Documentation for qualified vendors was often incomplete, and deficiencies identified during analytical lab audits were not followed up on, leading to the approval of unqualified service providers. This raises concerns about the quality and safety of products compounded and distributed by the firm.

Furthermore, the facility demonstrated deficiencies in its aseptic processing areas. Specifically, the contact time used for a sporicidal agent in critical controlled environments did not align with the product's label instructions, and the firm lacked qualification studies to support its chosen contact time, potentially compromising sterility.

Finally, labels for several compounded drug products were found to be deficient. They routinely omitted the required statement, "This is a compounded drug," and failed to include the dosage form, as mandated by Section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act. Notably, the labeling issues were a repeat observation from a previous FDA inspection. Avella Specialty Pharmacy is expected to implement prompt and comprehensive corrective actions to address these serious findings and ensure compliance.