Nebraska Devicemaker Slammed for Design Project Documentation

The FDA cited devicemaker Streck for failing to document certain design elements for its Cyto-Chex blood collection tubes, serving the company a Form 483 after a September inspection of its La Vista, Nebraska facility.

The investigator noted that the firm failed to fully document the design requirements for its Cyto-Chex blood collection tubes, which didn’t include how to construct the tube 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. It also didn’t state whether the stopper was made up of materials with low extractables and low outgassing properties.

In addition, verification of the blood collection tubes’ activities was not fully documented, as the firm did not complete verification data to identify potentially interfering substances extracted and/or outgassed from the tube. It also didn’t complete validation studies to specifically test for potential assay interference caused by such extractions.

The firm also lacked direct test methods to verify the concentration of the chelating agent ethylenediaminetetraacetic acid (EDTA) in the final product.

Read the full Streck Form 483 here: www.fdanews.com/11-29-18-streck483.pdf. — James Miessler