WASHINGTON — Inspectors from the U.S. health department discovered that the eye drop manufacturer, recently associated with deaths and injuries, failed to implement proper sterility measures at its facility in India.
During an inspection carried out from late February to early March, the Food and Drug Administration (FDA) unveiled close to a dozen issues with Global Pharma Healthcare’s eye drop production and testing methods. The FDA released its preliminary inspection report this Monday.
The company’s procedures were found inadequate for ensuring product sterility, according to FDA staff. The inspectors specifically pinpointed an unsatisfactory manufacturing process employed from December 2020 to April 2022 for products later sent to the U.S.
Located in the southern Indian state of Tamil Nadu, the facility manufactured eye drops associated with 68 bacterial infections in the U.S., including three deaths, eight cases of vision loss, and four surgeries to remove infected eyes. In February, the drops were recalled by two U.S. distributors, EzriCare and Delsam Pharma.
The outbreak is particularly alarming as the responsible bacteria display resistance to standard antibiotics.
Inspectors reached the facility on February 20, more than two weeks after the first eye drop recall announcement on February 3. According to agency records, this inspection appears to be the FDA’s inaugural visit to the plant.
The report presents the FDA’s preliminary conclusions, which are expected to be followed by an official report and a warning letter to the company. An FDA representative stated that the inspection implies the company’s products “may be in violation of FDA’s requirements.”
In a statement sent via email, FDA’s Jeremy Khan advised consumers to discontinue using these potentially dangerous products.
The FDA is responsible for ensuring the safety of foreign products imported to the U.S., but has long faced difficulties in keeping up with the increasingly intricate international pharmaceutical supply chains originating in India and China.
FDA inspectors pointed out troubling sanitation conditions at the Global Pharma facility, noting that its floors, walls, and ceilings were not easily cleanable. An FDA inspector observed during the visit that “none of the equipment on the filling machine was wrapped or covered.” Additionally, the inspector discovered that the company lacked rigorous procedures for verifying bottle seals, relying exclusively on manual visual inspections for leak detection.
Global Pharma has been largely silent about the recent recalls, referring questions to the U.S. companies that distributed the products.
<p “>In partnership with the Centers for Disease Control and Prevention (CDC), the FDA has been investigating the U.S. bacterial infections. CDC officials have detected the bacterial strain in opened EzriCare drop bottles obtained from infected patients, while the FDA is testing unopened bottles as well.
CDC officials are apprehensive about the bacteria spreading and foresee more cases being reported in the upcoming weeks and months. The agency recommends that healthcare facilities treating patients follow strict infection-control measures to avoid rapid dissemination of the germ.
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