FDA 483 - Innova Cosmetic Solutions LLC - November 06, 2019

Innovia Cosmetic Solutions LLC, an OTC drug manufacturer in Frostproof, FL, was cited for significant deficiencies across multiple systems during an FDA inspection. The firm exhibited inadequate laboratory controls, including a lack of potency and microbial testing, unvalidated test methods, and insufficient stability data for finished drug products. Additionally, the inspection revealed issues with quality control unit authority, absence of batch production records, failure to test incoming components, and use of inappropriately designed equipment.