EzriCare LLC

Selected passages from the FDA letter

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

Passage 1

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

Passage 2

you 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 CGMPs prior to being distributed in the United States.

Passage 3

you were unable to provide any written agreements or procedures that demonstrated you required your CMOs to meet CGMP requirements or make suitable release decisions of drug products for distribution into the U.S. supply chain.

Passage 4

your multidose ophthalmic drug product, labeled as EzriCare Artificial Tears, did not include a preservative, which in part rendered it injurious to health.

Passage 5

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

Passage 6

As a distributor, it is imperative that you communicate complaints to your CMO in a timely manner for appropriate follow-up.

Passage 7

Our analysis of intact (unopened) units found that 14 batches of EzriCare LLC’s Artificial Tears were non-sterile.

Passage 8

The testing of these intact units revealed that your ophthalmic drug products were intrinsically contaminated with microorganisms.

Passage 9

Pseudomonas aeruginosa isolates from three different batches of intact Artificial Tears samples collected by FDA were found to be close genetic matches to more than 85 clinical isolates associated with this outbreak.

Passage 10

In addition, two intact samples of EzriCare’s Artificial Tears from different batches were found to contain visible, foreign particles.

Passage 11

EZRICARE Artificial Tears is misbranded under section 502(j) of the FD&C Act, 21 U.S.C. 352(j), because it is not sterile.