Avella Specialty Pharma – FDA 483, Apr 19, 2018

The FDA inspection of Avella Specialty Pharmacy identified several deficiencies. The quality control unit failed to fully follow its responsibilities and procedures. Specifically, seven out of fourteen drug component, container closure, testing, and monitoring service vendors were not qualified according to SOPs 03HVOS.GEN-011 and 03HVOS-039. Three of these vendors were qualified in 2013 and 2014, but none have been re-qualified as required. Qualified vendors lacked complete documentation, such as forms GF-27 and QF-03, and critical information like licensing, accreditations, and FDA registration. In 2017, the firm compounded and distributed (b) (4) units of Bevacizumab using components from and tested by these unqualified/incompletely documented vendors.

Additionally, the quality unit failed to follow up on deficiencies observed during analytical lab qualification audits. For example, (b) (4) was approved as a qualified analytical service provider in 2013 despite five "Needs Improvement" items on its audit checklist, with no documented corrective and preventive actions, and has not been re-audited since.

Aseptic processing areas were deficient in cleaning and disinfecting equipment. The firm used (b) (4) as a sporicidal agent in ISO 5 hoods with a (b) (4) contact time, which contradicts the label's direction for (b