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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
A Seattle, Washington devicemaker drew a Form 483 after a March inspection by the FDA revealed the facility lacked procedures for medical device reporting and had other significant nonconformances. Read More
The agency said applicants should determine the biocompatibility of all parts in the biliary stent and the delivery system that touch the patient. Read More