FDA WARNING_LETTER - EzriCare LLC - March 21, 2023
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The FDA inspected EzriCare LLC (FEI 3022210898) from March 8-21, 2023, following an inspection of their contract manufacturing organization (CMO), Global Pharma Healthcare Private Limited, which revealed significant CGMP violations. EzriCare LLC, a distributor of EzriCare Artificial Tears, was found to have received and distributed adulterated and misbranded drugs.
FDA testing of intact EzriCare Artificial Tears samples revealed 14 non-sterile batches, with Pseudomonas aeruginosa isolates from three batches genetically matching clinical isolates from a multistate outbreak linked to 80+ patients, 4 deaths, and 14 vision loss cases. Two samples also contained visible foreign particles. This renders the products adulterated under sections 501(a)(1) and 501(a)(2)(A) of the FD&C Act.
The inspection of EzriCare LLC revealed failures in having adequate procedures for ensuring drug quality, including insufficient supplier qualification and lack of written agreements requiring CMOs to meet CGMP. EzriCare's multidose ophthalmic product lacked a preservative, contributing to its injurious nature. The firm also lacked written procedures for handling product complaints and failed to document and investigate them.
EzriCare Artificial Tears is misbranded under section 502(j) of the FD&C Act because it is not sterile, violating 21 CFR 2
ID · c4537155-ab6a-4eb6-903d-9182886dc5d3
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