Delsam Pharma LLC

Selected passages from the FDA letter

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

Passage 1

Our analysis of intact (unopened) units found that four batches of Delsam Pharma’s Artificial Tears were non-sterile.

Passage 2

FDA tested 20 units, and 1 unit was found to allow microbiological ingress, which confirmed that your container-closure system lacks integrity and is insufficient for maintaining sterility.

Passage 3

your firm failed to have adequate procedures to ensure that all ophthalmic drug products produced for your firm met appropriate quality attributes and were free of microbial contamination.

Passage 4

You also failed to have adequate supplier qualification procedures to ensure that the drug products received from Global Pharma Healthcare Private Limited were manufactured in compliance with CGMP prior to being distributed in the United States.

Passage 5

you lacked written procedures describing the handling of all written and oral complaints regarding your drug products and failed to document and investigate complaints that were received.

Passage 6

Delsam Pharma’s ARTIFICIAL TEARS and Delsam Pharma’s ARTIFICIAL EYE OINTMENT are misbranded under section 502(j) of the FD&C Act, 21 U.S.C. 352(j), because they are not sterile.

Passage 7

the principal display panel (PDP) of the product label purports the product to be “sterile.” However, FDA analysis of samples of Delsam Pharma’s ARTIFICIAL EYE OINTMENT determined that it was contaminated with microorganisms including *Burkholderia cepacia* complex.