FDA WARNING_LETTER - Global Pharma Healthcare Private Limited - March 02, 2023

The FDA issued a Warning Letter to Global Pharma Healthcare Private Limited following a February 20 to March 2, 2023, inspection of their Thiruporur, India facility, identifying significant Current Good Manufacturing Practice (CGMP) violations. This inspection was prompted by a December 2022 multi-state outbreak of antibiotic-resistant *Pseudomonas aeruginosa* infections linked to the company's Artificial Tears products, resulting in patient deaths and vision loss.

FDA testing revealed 18 batches of Artificial Tears and one batch of Artificial Eye Ointment were non-sterile, with *Pseudomonas aeruginosa* isolates from three Artificial Tears batches genetically matching outbreak strains. This intrinsic contamination led to the products being deemed adulterated under 21 U.S.C. 351(a)(2)(A) and (B), and misbranded under 21 U.S.C. 352(j) for non-sterility. Delsam Pharma’s Artificial Eye Ointment was additionally misbranded under 21 U.S.C. 352(a) for falsely claiming sterility.

Key violations included: 1. **Failure to prevent microbiological contamination (21 CFR 211.113(b)):** Inadequate aseptic filling machine qualification, unvalidated sterilization processes (including a contractor's process), insufficient media fills, lack of dynamic airflow studies, and unreliable container-