Following the FDA’s decision to expand its unpaid work to include inspection activities that are beyond “for-cause” inspections, Commissioner Scott Gottlieb announced on Tuesday that approximately 400 staff members will return to their p... Read More
The FDA cited GlaxoSmithKline’s East Durham, New York facility for failing to follow standard operating procedures. Read More
A 12-item 483 documents a litany of quality system failures the FDA found at Diasol East of Watertown, Tenn., during an Aug. 7 to Aug. 22 inspection. Read More
The FDA hit Monmouth Junction, New Jersey device manufacturer Replication Medical with a Form 483 following an inspection that revealed issues with the firm’s documentation of corrective and preventive action activities and device histor... Read More
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