FDA 483 - NCM USA LLC - December 08, 2017

NCM USA Bronx LLC, a PET drug manufacturer in Bronx, NY, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm was cited for failures in equipment maintenance, inadequate control of testing supplies, and inaccuracies in master production records. Additionally, the inspection revealed issues with the firm's change control processes for specifications and procedures, and a lack of adherence to written quality assurance protocols for environmental monitoring.