FDA uncovers multiple issues at eye drop factory linked to deadly outbreak.
The FDA has found several manufacturing violations at Global Pharma's facility, including brown slime on filling equipment and a lack of basic measures to ensure sterility. The company's eye drops were linked to a deadly outbreak of extensively drug-resistant infections in the US, with 68 people infected and three deaths reported. The FDA had warned consumers to stop using the products, and Global Pharma later issued voluntary recalls. The inspection report outlines eleven "observations" of failures, with specifics, including a lack of validation data to demonstrate that the company's filtration system can "reliably sterilize" the eye drops.