U.S. inspectors found dirty equipment and other issues at an eye drops factory as officials investigate a serious outbreak of bacterial infections, some of which have led to deaths.
U.S. Food and Drug Administration (FDA) inspectors saw “black, brown colored greasy deposit” on one machine and found the machine had not been cleaned for weeks, according to documents made public by the FDA about five weeks after a Feb. 21 inspection of the factory. (pdf).
Inspectors also said Global Pharma Healthcare Pvt Ltd, which runs the factory in India, failed to properly sterilize equipment, perform aseptic techniques, and ensure products were sterile….