FDA 483 - SOLA Pharmaceuticals LLC - December 18, 2024

SOLA Pharmaceuticals LLC, an Own Label Distributor in Baton Rouge, LA, was cited for significant deficiencies related to its quality control unit during an FDA inspection. The firm lacked an established quality control unit and failed to adequately assess the competency of its Contract Manufacturing Organizations. Additionally, the responsibilities and procedures for the quality control unit were not documented in writing, with the firm relying solely on FDA databases for CMO evaluations instead of on-site assessments.