FDA WARNING_LETTER - Delsam Pharma LLC - March 24, 2023

The FDA issued a Warning Letter to Delsam Pharma LLC following a March 6-24, 2023, inspection, prompted by violative conditions at their contract manufacturer, Global Pharma Healthcare Private Limited. The inspection revealed Delsam Pharma LLC, as a distributor of ophthalmic drugs, received and distributed adulterated and misbranded products.

FDA testing of Delsam Pharma’s Artificial Tears and Artificial Eye Ointment, manufactured by Global Pharma, found multiple batches to be non-sterile, intrinsically contaminated with microorganisms (e.g., Bacillus species, Burkholderia cepacia complex), and one Artificial Eye Ointment batch had a compromised container-closure system. These findings led to the products being deemed adulterated under sections 501(a)(2)(A), 501(a)(2)(B), and 501(a)(1) of the FD&C Act, and misbranded under section 502(j) (non-sterile ophthalmic preparations) and 502(a) (false labeling of sterility) of the FD&C Act.

Delsam Pharma LLC failed to implement adequate procedures for ensuring product quality, microbial contamination control, and supplier qualification for their CMO. They also lacked written procedures for handling and investigating product complaints, and for communicating complaints to their CMO.

Global Pharma Healthcare Private Limited was cited for significant CGMP violations, including inadequate filling equipment, unvalidated