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 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
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
Company Announcement
Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level, due to possible contamination. The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)- producing carbapenem-resistant 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.
Risk Statement: Use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.
Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, ½ fl oz (15 ml) bottle are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun. The product is packaged in a bottle with a safety seal and are placed in a carton box Ezricare NDC 79503-0101-15, UPC 3 79503 10115 7; Delsam Pharma’s NDC 72570-121-15, UPC 3 72570 12115 8. It can be identified by the photos below. The product was distributed Nationwide in the USA over the Internet.
Global Pharma Healthcare is notifying the distributors of this product, Aru Pharma Inc. and Delsam Pharma and is requesting that wholesalers, retailers and customers who have the recalled product should stop use.
Consumers with questions regarding this recall can contact the distributors: Aru Pharma/Ezricare, LLC by phone: 1-516-715-5181 or by e-mail: arupharmainc@yahoo.com from Monday to Friday, 11am to 4pm EST; or DELSAM Pharma LLC by phone: 1-866-826-1306 or by e-mail: delsampharma@yahoo.com from Monday to Friday from 11am to 4pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level, due to possible contamination. The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)- producing carbapenem-resistant 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.
Risk Statement: Use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.
Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, ½ fl oz (15 ml) bottle are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun. The product is packaged in a bottle with a safety seal and are placed in a carton box Ezricare NDC 79503-0101-15, UPC 3 79503 10115 7; Delsam Pharma’s NDC 72570-121-15, UPC 3 72570 12115 8. It can be identified by the photos below. The product was distributed Nationwide in the USA over the Internet.
Global Pharma Healthcare is notifying the distributors of this product, Aru Pharma Inc. and Delsam Pharma and is requesting that wholesalers, retailers and customers who have the recalled product should stop use.
Consumers with questions regarding this recall can contact the distributors: Aru Pharma/Ezricare, LLC by phone: 1-516-715-5181 or by e-mail: arupharmainc@yahoo.com from Monday to Friday, 11am to 4pm EST; or DELSAM Pharma LLC by phone: 1-866-826-1306 or by e-mail: delsampharma@yahoo.com from Monday to Friday from 11am to 4pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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