FDA 483 - Perrigo New York, Inc. - May 08, 2026

Perrigo New York, Inc. received a Form 483 following an inspection of its Bronx, NY drug manufacturing facility, revealing significant deficiencies in environmental controls, personnel practices, equipment maintenance, and facility upkeep. Observations included inadequate air pressure control, improper gowning procedures leading to contamination risks, failure to protect cleaned equipment, and poor building maintenance with cracked floors and dislodged ceiling tiles. These issues indicate a moderate level of severity concerning GMP compliance.