FDA 483 - Brand-Nu Laboratories, Inc. - November 22, 2021

An FDA inspection conducted at Brand-Nu Laboratories, LLC, an API/Excipient repacker in Meriden, Connecticut, from November 10 to November 22, 2021, identified significant deviations from Current Good Manufacturing Practices (cGMP). The inspection revealed two primary areas of concern.

Firstly, the firm's Quality Control Unit (QCU) did not consistently follow established procedures. Observations included the absence of required quality reviews for cleaning records in 2021 and for environmental monitoring data and cleanroom performance test reports from 2019-2020 for repackaging cleanrooms. Additionally, Brand-Nu failed to complete annual product reviews for Sodium Chloride USP and Sodium Acetate products in 2020, a mandatory step per their internal guidelines for cGMP-repacked items.

Secondly, deficiencies in employee cGMP training were noted. One production employee lacked documented completion of their 2019 annual training, while another's 2018 training verification by a supervisor was missing. Notably, inadequate training documentation was also cited in a previous 2017 FDA inspection, indicating a recurring issue.

Brand-Nu Laboratories, LLC is required to implement thorough corrective and preventive actions to rectify these observed deficiencies, ensuring their operations meet cGMP standards for quality oversight and personnel training.