Serious Incredible Super Power made Eye Drops causes infection to AMDKs eyes!

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FDA inspection finds sterilization issues at recalled eye drop manufacturer’s facility​

CNN — none
The manufacturer of eye drops that have been linked to an outbreak of serious bacterial infections in the US, including at least three deaths, did not follow proper protocol to prevent contamination of its products, according to an inspection report published Friday by the US Food and Drug Administration.

The FDA visited a Global Pharma Healthcare facility in India for an inspection that started in mid-February, 2½ weeks after the company recalled EzriCare Artificial Tears due to possible contamination.

At the time of the recall, there were 55 reports of adverse events including eye infections, permanent loss of vision and at least one death with a bloodstream infection. As of late last month, 68 infections had been identified in 16 states, according to the US Centers for Disease Control and Prevention. There have been three deaths, eight cases of vision loss and four surgical eye removals reported.

An 11-day inspection of the Global Pharma facility resulted in 11 observations by the FDA, including a “manufacturing process that lacked assurance of product sterility,” specifically for batches of product that were manufactured between December 2020 and April 2022 and shipped to the US.

The EzriCare Artificial Tears product, which is manufactured by Global Pharma, is part of an outbreak of infections from bacteria called Pseudomonas aeruginosa.

This rare drug-resistant bacteria can spread among people who don’t have symptoms – and to people who haven’t used the eye drops, according to the CDC. This type of spread is particularly common in health care settings.

“The bacteria can spread when one patient carrying the bacteria exposes another patient, or when patients touch common items or when healthcare workers transmit the germs which is why infection control, like hand hygiene, is so important,” the agency told CNN in an email Monday.

Several cases in the current outbreak have been identified in people who were carrying the bacteria without signs or symptoms of clinical infections, the CDC said. These cases were discovered through screenings at inpatient health care facilities that had clusters of infections.

The particular strain of the bacteria associated with this outbreak had never before been reported in the US, and related infections have been identified at acute care hospitals, long-term care facilities, emergency departments, urgent care clinics and other outpatient facilities.

People affected by the outbreak reported using different brands of artificial tears, but EzriCare Artificial Tears was most commonly reported.

The FDA inspection of the Global Pharma facility is part of an ongoing compliance matter.

“The FDA’s highest priority is protecting public health – this includes working with manufacturers to quickly remove unsafe drugs from shelves when they are identified,” the agency said in an email Monday. “The FDA continues to monitor this issue and is working with the Centers for Disease Control and Prevention (CDC) and the companies recalling these affected products. We urge consumers to stop using these products which may be harmful to their health.”

 

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FDA finds dirty equipment, dozens of other issues at eye drops factory linked to deadly outbreak​

April 3, 2023 / 9:02 AM

By Alexander Tin
Federal inspectors found dozens of issues at an eye drops manufacturer now linked to a fatal outbreak of drug-resistant bacteria, inspection records released by the Food and Drug Administration show, ranging from dirty equipment and clothing to missing safeguards and procedures.

The FDA's findings were detailed in citations issued to Indian manufacturer Global Pharma Healthcare Pvt Ltd after an inspection from February 20 through March 2. This appears to have been the company's first visit from the FDA to their plant in India: no other inspections are on record for the site.

That inspection came in the wake of a swelling multistate outbreak of rare and extensively drug-resistant bacteria that was linked to eye drops manufactured by the firm, which had been branded as EzriCare and Delsam Pharma.

Dozens of people have been infected in the outbreak, which has included at least eight reports of vision loss and three deaths, the Centers for Disease Control and Prevention says. All of the "artificial tears" eye drops made by the company linked to the outbreak have since been recalled.

• Here's what you need to know about the flurry of eye drop recalls

"You used a manufacturing process that lacked assurance of product sterility," the FDA says in the document, which was first reported by STAT News.

Among a range of issues, the FDA's inspectors say they found evidence of poor cleaning procedures throughout the facility and substantial gaps in written procedures and training for workers at the plant. Scrutinizing the company's records also turned up unexplained discrepancies.

During the agency's visit, booties being used in the company's cleanrooms were observed to be "discolored, and worn-out." The company "did not track or have studies to show how many times" clothing could be reused by workers.

During one walk-through, an inspector "saw a black, brown greasy deposit" on part of one of the company's machines to fill its product into bottles. Logs claimed the machine had been cleaned just weeks before and had not been used since.

Surfaces that came into contact with the packaging "were not cleaned, sanitized, decontaminated, or sterilized" at all. There were also gaps and discrepancies in records of how key filling machines and spaces were cleaned.

Some key tests to double check that products coming off the company's lines were sterile were never done, the agency found, while others that had actually been performed were never validated.

Surfaces around the plant also seemed hard to clean thoroughly. The inspectors noted one filling room had "soft, unsmooth, and cracked sealant, protruding nails, and nail holes" across its walls.

The company also fell short of double checking the ingredients it used to produce its products, instead relying on assurances from their suppliers.

"Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals," the inspectors wrote.

Drug-resistant bacteria​

Early in the outbreak, authorities had only turned up evidence of the bacteria in already-opened bottles of Global Pharma Healthcare's products. That left open the possibility of another source for the outbreak. Testing from still-closed artificial tears products looked clean.

Authorities had faulted the company for not using preservative in its reusable eye drops bottles, which raised the risk of bacteria growing in opened bottles.

But the FDA later expanded their warning to another eye product manufactured by Global Pharma — Delsam Pharma's Artificial Eye Ointment — after an analysis by the agency "found unopened tubes to be contaminated with bacteria." 50,000 products were recalled of that ointment.

It is unclear what bacteria the FDA turned up in its analysis and whether it matches the strain in the fatal outbreak.

Representatives for FDA and for Global Pharma did not immediately return requests for comment.

The strain in the outbreak — a type of drug-resistant Pseudomonas aeruginosa — is so rare that it had never been reported in the U.S. before.

Doctors have few options for treating patients battling these infections, though there is a potential treatment using phage therapy — deploying viruses that essentially eat bacteria — which researchers at the University of California San Diego's Center for Innovative Phage Applications and Therapeutics identified earlier this month.