FDA 483 - BIT Group USA, Inc. - December 11, 2019

An FDA inspection of BIT Group USA, Inc., a contract manufacturer in San Diego, CA, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for controlling non-conforming product, specifically lacking requirements for investigation evaluations. Additionally, procedures for corrective and preventive actions were found to be inadequate, with a specific CAPA record missing a documented investigation into the root cause of a non-conformance.