FDA Hands 483 to Dialysis Medical Solutions for CAPA, Quality Lapses

Dialysis Medical Solutions received a Form 483 for inadequate documentation for corrective and preventive action and other quality failures for its dialysis products.

The inspector noted during a January 2016 inspection at the firm’s Lewisberry, Pa., facility, that a CAPA was not opened when there was an increase in the number of investigations during a three-month period for laboratory and production investigations in 2015.

The agency also cited the firm for inadequate procedures for receiving, reviewing and evaluating complaints.

Also, the firm failed to adequately establish procedures to control products that don’t conform to specified requirements. For example, the procedure for nonconforming products “does not specify or reference which forms are to be completed or what ‘document accordingly’ means,” the 483 says.

Dialysis Medical also failed to establish adequate procedures for management reviews. Its management review procedure doesn’t explain how to re-audit “deficient matters,” and a list of managers in attendance during audits is not documented even though the firm’s quality manual specifically identifies the senior managers who should attend.

Finally, procedures for design review were not adequately established, the agency said, noting that the firm’s design control procedure doesn’t ensure that formal reviews of design results are “planned and conducted at appropriate stages of the device’s design development,” the 483 says.

The firm did not respond to a request for comment by press time. Read the Form 483 here: www.fdanews.com/05-05-16-DialysisMedical.pdf. — Tamra Sami