Omni Lens Pvt. Ltd. – FDA Warning Letter, Sep 27, 2024

On October 2, 2024, the FDA issued a Warning Letter to Omni Lens Pvt. Ltd., an OTC drug manufacturer in Ahmedabad, Gujarat, India, following a review of records submitted on November 21, 2023, and April 5, 2024. The FDA found significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include the firm's quality control unit failing to ensure CGMP compliance and meet product specifications (21 CFR 211.22). Omni Lens Pvt. Ltd. improperly delegated quality unit responsibilities to contract manufacturing organizations (CMOs) without adequate oversight. Records showed CMOs lacked adequately designed aseptic processing rooms and failed to perform dynamic airflow visualization studies and effectiveness testing for benzalkonium chloride-containing ophthalmic products.

Additionally, "Green Glo, NDC 17238-920," "BioGlo, NDC 17238-900," and "Vista Gonio Eye Lubricant, NDC 77790-022" were deemed misbranded because they were manufactured in facilities not duly registered with the FDA, violating 21 U.S.C. 331(a) and 21 U.S.C. 360.