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Medical Devices / Inspections and Audits

Nebraska Devicemaker Hit for Design Documentation

Dec. 3, 2018
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The FDA called out medical device manufacturer Streck for failing to document certain design elements for its Cyto-Chex blood collection tubes, sending the company a Form 483 after conducting a September inspection of its La Vista, Nebraska facility.

The investigator noted that the firm failed to fully document the design requirements and how to construct the collection tubes from inert materials.

The facility also failed to adequately document design outputs, including documentation for the tube’s rubber stopper design, composition and material properties.

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