Global Pharma Healthcare recalled all lots of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, due to possible contamination. This product was identified by CDC as the source of "Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare. To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection."
The 483 Report (obtained from www.marlerblog.com) details an extremely bad operation.
(https://www.marlerblog.com/files/2023/04/Global-Pharma-Healthcare-Ltd.-Tamilnadu-India-3.2.23-483.pdf)
This is an imported product. We often wonder why some items are less expensive than branded products that are produced in the US. Products produced in the US have to meet established sanitary standards.
Observations from the report include:
Obs 1A. Lack of validation support for demonstrating the equipment can be reliably sterilized. And with that, the procedures were not followed for the required sterility filters.
Obs 1B. Improper filter testing
Obs 1C. Did not perform container closure integrity test adequately.
Obs 1D. Formulation not followed, specifically with inadequate preservatives.
Obs 1E Aseptic process lacked sterility assurance
Obs 1F. Airflow patterns insufficient (to demonstrate air control in aseptic environment)
Obs 1G Floors, walls, and ceilings were not appropriate for aseptic processing - cracks, holes, etc
Obs 1H Employees not qualified, did not follow appropriate procedures for aseptic environment.
Obs 2 - Test methods not established for accuracy, sensitivity, and reproducibility.
Obs 3 - Equipment does not have appropriate deisgn for how it is being used.
Obs 4 - Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic products. Including (C) surfaces that contact the container closures is not cleaned.
Obs 5 - Failed to conduct test to verify identity of each component of the eye products.
Obs 6 - Failed to establish written procedures for cleaning and maintaining the equipment.
Obs 7 - Defient environmental monitoring.
Obs 8 - Laboratory controls do not have specifications for conformance - what is acceptable.
Obs 9 - REcord reviews not completed and approved by QC
Obs 10 - Stability samples not stored according to written procedures
Obs 11 - QC does not have responsibility and authority to approve, reject.
Yikes.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-pharma-healthcare-issues-voluntary-nationwide-recall-artificial-tears-lubricant-eye-drops-due
Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination
Summary
Company Announcement Date: February 02, 2023
FDA Publish Date: February 02, 2023
Product Type: Drugs
Reason for Announcement: Potential microbial contamination
Company Name: Global Pharma Healthcare
Brand Name: EzriCare & Delsam Pharma
Product Description: Artificial Tears Lubricant Eye Drops