FDA 483 - Perrigo New York, Inc. - January 22, 2019

Perrigo New York, Inc. in Bronx, NY, a drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included a failure to thoroughly investigate out-of-specification stability lots and inadequate written procedures for cleaning and maintenance, specifically regarding cleaning validation and assessment of cleaning effectiveness after multiple batch campaigns. These issues indicate a lack of robust quality control and manufacturing process validation.