Omni Lens Pvt. Ltd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm lacked an adequate quality unit (QU) to exercise appropriate procedures and controls to ensure your over-the counter (OTC) drug products are manufactured in compliance with CGMP.

Passage 2

your CMO lacks an adequately designed aseptic processing room where ophthalmic drop products are manufactured and has not performed the following: • Dynamic airflow visualization studies for aseptic processing

Passage 3

• (b)(4) effectiveness testing for benzalkonium chloride containing ophthalmic products

Passage 4

“Green Glo, NDC 17238-920,” “BioGlo, NDC 17238-900,” and “Vista Gonio Eye Lubricant, NDC 77790-022” are manufactured at (b)(4) and (b)(4), establishments that are not duly registered with FDA. Under section 502(o) of the FD&C Act, a drug is misbranded if it was manufactured in an establishment not duly registered under section 510. Therefore, “Green Glo, NDC 17238-920,” “BioGlo, NDC 17238-900,” and “Vista Gonio Eye Lubricant, NDC 77790-022” are misbranded drugs under section 502(o) of the FD&C Act.