FDA 483 - Avella Specialty Pharmacy - April 19, 2018

The FDA Form 483 details observations from an inspection of Avella Specialty Pharmacy, an outsourcing facility.

**Violations and Observations:**

1. **Failure to Fully Follow Quality Control Unit Procedures:** * **Vendor Qualification:** The firm's SOPs (03HV05-GEN-011 and 03HV05-039) for vendor qualification were not followed. * Seven out of fourteen vendors supplying drug components, container closures, and testing/monitoring services were not qualified. * Two vendors qualified in 2013 and one in 2014 had not been re-qualified every (b)(4) as required by SOPs. * Qualified vendors lacked complete documentation, including form GF-27 Vendor Qualification Questionnaire and/or form QF-03 Outside Lab Quality Audit. * The firm failed to collect licensing, accreditations, and FDA registration for several vendors. * In 2017, (b)(4) units of Bevacizumab were compounded and distributed using materials from unqualified vendors and tested by these vendors. * **Analytical Lab Qualification Audit Follow-up:** The quality unit failed to follow up on deficiencies observed during analytical lab qualification audits. * For example, (b)(4) was approved as a qualified supplier in 2013 despite five "Needs