FDA lambastes GSK plant for releasing contaminated products

Much has been made as of late of the manufacturing problems found at some of India's biggest drugmakers. But a warning letter sent in March to a GlaxoSmithKline ($GSK) active pharmaceutical ingredient (API) plant in Cork, Ireland, illustrates that Big Pharma is not immune to quality issues. The warning letter posted today on the FDA website says the facility released some products made with solvents contaminated from a "waste tank." The highly redacted letter does not identify the products or the contaminants but says one product was held after testing, suggesting problems, but another was shipped. It also lambastes the U.K. drugmaker for deciding that the issue did not warrant telling its customers and for determining there was no reason to believe the products were affected. "We are concerned that your firm does not consider the entry of pharmaceutical waste streams into your manufacturing process a significant deviation with a potential quality impact," the FDA told the drugmaker. Warning Letter | More

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