Devices & Diagnostics Letter

May 28, 2012 | Vol. 39 No. 22

Branan Medical Gets Closeout Letter Resolving Clearance Concerns

Branan Medical, a maker of drug testing kits, received an FDA closeout letter resolving myriad marketing clearance and manufacturing concerns cited in a 2009 warning letter.

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Inadequate GMPs Garner Warning Letter for Italian Devicemaker Stryker Warning Letter, Form 483 Show Corrective Action Concerns Devicemaker Surprised by Warning Letters, Had Responded to 483 Va. Kit Company Gets Closeout Letter on GMP Gaps, Unapproved Product

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