FDA 483 - Swabplus, L.P. - August 01, 2023

Swabplus, L.P., a contract repacker in Rancho Cucamonga, CA, received an FDA Form 483 with ten observations following an inspection from July 25 to August 1, 2023. The findings reveal significant deficiencies across quality control, production processes, laboratory controls, equipment design, and facility maintenance. Repeat observations include failures in purified water system sanitization and inadequate audit trail review, indicating systemic issues with GMP compliance that pose risks to drug product quality.