www.fdanews.com/articles/177956-maryland-manufacturer-receive-fda-form-483-over-sterility
Maryland Manufacturer Receive FDA Form 483 Over Sterility
August 12, 2016
A Maryland manufacturer received a three-observation Form 483 after an inspection revealed inadequate sterility controls.
An inspection of Pharmaceutics International’s facility in Huntsville uncovered a slew of deficiencies tied to the sterility assurance of its cancer, osteoporosis and nausea products.
The 483 details instances when operators neglected to follow proper protocol, placing products at risk for contamination.