Global Pharma Healthcare Private Limited

Warning LetterOpen

Dr. A.R. Venkatesh Chief Executive Officer Global Pharma Healthcare Private Limited A-9 SIDCO Pharmaceutical Complex Thiruporur 603110 Tamil Nadu IndiaFEI 3012323885Issued Oct 20, 2023Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012323885.

Violations9

Issue DateOct 20, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Global Pharma Healthcare Private Limited
Location: Dr. A.R. Venkatesh Chief Executive Officer Global Pharma Healthcare Private Limited A-9 SIDCO Pharmaceutical Complex Thiruporur 603110 Tamil Nadu India
FEI Number: 3012323885
Country: India
Issue Date: October 20, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Global Pharma Healthcare Private Limited received a warning for significant Current Good Manufacturing Practice (CGMP) violations at its drug manufacturing facility in Tamil Nadu, India, discovered during an FDA inspection in February-March 2023. The company's finished pharmaceutical products were found to be adulterated due to non-conforming manufacturing methods, facilities, and controls, as well as preparation under insanitary conditions that risked contamination with filth and potential harm to health. Specific products including EZRICARE Artificial Tears, Delsam Pharma's Artificial Tears, and Delsam Pharma's Artificial Eye Ointment were also cited as misbranded. The warning was issued in connection with an FDA and CDC investigation into a multistate outbreak of antibiotic-resistant Pseudomonas aeruginosa infections that affected over 80 patients, resulting in 4 deaths.

Global Pharma Healthcare Private Limited FDA Warning Letter, October 20, 2023