Catalent Greenville Inc – FDA EIR, May 2, 2014

An FDA surveillance and pre-approval inspection of Metrics, Inc. dba Coastal Pharma, a drug product manufacturer and control laboratory in Greenville, NC, was conducted from April 29 to May 2, 2014. The inspection was performed under Compliance Programs 7356.002 (Drug Manufacturing Inspection) and 7346.832 (Pre-Approval Inspections/Investigations), ensuring adherence to the Food Drug and Cosmetic Act. Overall, the inspection concluded without significant objectionable conditions, and no Form FDA 483 (Inspectional Observations) was issued to the firm.However, several minor observations were noted and discussed with management. These included a crack in a wall and a damaged gasket around a light fixture in manufacturing areas. The firm also needed to improve its deviation management, specifically by developing formal processes and written justifications for canceled deviations, as some lacked proper closure documentation. Additionally, the timeliness of verifying and updating equipment calibration stickers after calibrations was addressed. While these items did not lead to an FDA 483, the FDA stressed that, if not corrected, they could be considered violations and potentially result in future regulatory actions.