Mccrone Associates, Inc. – FDA EIR, Jan 15, 2019

An FDA establishment inspection of McCrone Associates, Inc., located in Westmont, IL, was conducted from January 10 to January 15, 2019. This inspection, carried out under Compliance Programs 7356.002 (Drug Manufacturing Inspections) and 7371.001 (Animal Drug Manufacturing Inspections), specifically covered the Quality and Laboratory Control systems related to drug current Good Manufacturing Practices (cGMP). The purpose was to assess the firm's contract testing operations for particle identification and material characterization. During the inspection, which included a facility tour and review of quality assurance and quality control testing procedures, data records, equipment qualification, and CAPA processes, no significant objectionable conditions were observed. Consequently, the FDA did not issue a Form 483, "Inspectional Observations." This indicates that McCrone Associates, Inc. was found to be operating in compliance with the relevant regulatory requirements within the scope of the inspection. No specific violations or issues were identified, and therefore, no regulatory actions or follow-up actions were required by the FDA.