483
Auro PR IncAuro PR Inc – FDA 483, Mar 15, 2018
Record Details
Mylan LLC in Caguas, PR, a drug manufacturer, was cited with four observations during an FDA inspection. The inspection revealed deficiencies in the visual examination of received components, the qualification and calibration of dissolution testing instruments, and the cleaning and maintenance procedures for equipment and utensils. These issues indicate a lack of adequate controls to ensure product quality and integrity.
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ID · e251f642-af25-442e-aa4f-6709f8740d8b
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