FDA 483 - Profounda Inc - August 30, 2024

Profounda Inc, an OTC drug manufacturer and own label distributor in Orlando, FL, was inspected and cited for significant deficiencies across its quality system, laboratory controls, and production system. Key issues include a lack of defined quality unit responsibilities, deficient complaint handling procedures, unvalidated microbiology test methods, and unvalidated cleaning processes for equipment. This inspection highlights fundamental gaps in GMP compliance, with one observation being a repeat finding.