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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 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
Republic Spine found itself in hot water with the FDA for inadequate risk analysis and CAPA procedures as well as failure to develop written medical device procedures and design controls, following a March 2018 inspection of its Boca Raton, Florida facility. Read More
Work instructions contained in two device master records were incorrect and the company did not maintain its electronic device master records as instructed by its procedure. Read More
Republic Spine: Republic Spine found itself in hot water with the FDA for inadequate risk analysis and CAPA procedures as well as failure to develop written medical device procedures and design controls, following a March 2018 inspection of its Boca Raton, Florida facility. Read More
Republic Spine found itself in hot water with the FDA for inadequate risk analysis and CAPA procedures as well as failure to develop written medical device procedures and design controls, following a March 2018 inspection of its Boca Raton, Florida facility. Read More