FDA 483 - Neva Analytics, LLC - February 06, 2019

An FDA inspection of Next Analytics, LLC, a contract testing laboratory in Longmont, CO, revealed significant deficiencies in their quality systems. Observations included a lack of validation for computerized systems and equipment, inadequate laboratory controls with no formal Out of Specification (OOS) investigation procedure, and insufficient controls over computer systems allowing data deletion and lacking backup procedures. Additionally, the firm failed to establish formal procedures for handling drug product complaints.