South Korean Needle Maker Gets 483 After Stacking Needle Bins

June 20, 2014

During an FDA inspection, an employee of Precision Needle Manufacturing placed a bin of needle protectors on the ground and then later stacked the same bin on top of another container with exposed needle protectors, according to a Form 483.

This action was taken in the manufacturing area where sterile and nonsterile products, including spinal needles and epidural needles, are assembled, according to the Jan. 9 form, which was recently released.

The South Korean manufacturer also failed to outline in its purchasing procedure the actions that should be taken when a category 2 supplier falls short of the minimum overall quality score. “One category 2 supplier did not meet the … score yet no action was taken by the inspected firm,” the form says.

Meanwhile, no supplier audit was conducted for a category 2 supplier in 2012, and the company’s purchasing procedure did not specify the frequency of supplier audits.

Out of three CAPA files reviewed, none included documentation of root cause investigations. Precision’s CAPA procedure lacked requirements for verifying and validating CAPAs and for implementing and recording necessary changes.

Three of five nonconforming records reviewed by the FDA investigator did not adequately record the disposition of nonconforming product after sorting activities, and one did not record the justification for use of nonconforming product.

None of the five complaint records reviewed had all of the documentation required by the company’s procedure. They lacked dates and results of the investigation, corrective actions taken and replies to the complainant.

Precision could not be reached for comment by press time.

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