Sun Pharma facility under an import alert handed a warning letter
A manufacturing site belonging to a major generics manufacturer in India has been given a warning letter from the FDA after it was placed on an import alert.
The FDA’s letter, which was sent on Dec. 15, involves a 23-page Form 483 inspection in April and May of last year and its subsequent response by Sun Pharma.
During the FDA’s initial inspection, several violations were noted, which included not accurately simulating commercial operations and “poor aseptic techniques.” These techniques included an operator inserting a gloved hand inside a canister, someone touching the “product contact surface” of a stopper before placing it back into a canister, and movements from the operators in “critical areas” not always being slow and deliberate, among others.
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