FDA Issues Warning to Shoolin Pharma Over Unsanitary Conditions

In a recent inspection, the Food and Drug Administration (FDA) discovered troubling sanitary issues at Shoolin Pharma, an active pharmaceutical ingredient supplier based in Gujarat, India. The inspection, which took place in April, revealed significant cleanliness concerns that have led to serious regulatory repercussions.

The inspector reported that production areas were marred by residue and stains on walls, floors, and equipment. Additionally, corrosion was noted on a product line, raising alarms about potential contamination. Compounding these issues was the sight of an employee wearing open-toed sandals in a manufacturing environment, a clear violation of sanitary protocols.

As a result of these findings, the FDA has taken action to protect public health by halting all shipments from Shoolin Pharma to the United States. This decision was detailed in an August 18 warning letter published on the FDA's website, which cited not only the unsanitary conditions but also incomplete laboratory testing records as factors in the agency's decision.

Source: www.statnews.com