The FDA cited Pfizer’s Hospira manufacturing facility in Sriperumbudur, Tamil Nadu for a slew of repeat deficiencies, including falsifying data, in a Form 483 flagged as Official Action Indicated – indicating that the agency is planning ... Read More
The FDA cited Q A Laboratories after a lengthy inspection of its of Kansas City, Missouri facility revealed serious sanitation deficiencies and other nonconformances. Read More
The FDA cited device manufacturer Sybaritic of Bloomington, Minnesota following a Feb. 22 to March 7 inspection for failing to comply with the terms of a consent decree. Read More
The FDA issued Summit Medical a Form 483, citing issues with CAPA and incoming product acceptance procedures as well as process validation shortcomings. Read More
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