A company that manufactures and repackages solutions used in kidney dialysis was cited by the FDA for selling products that failed quality tests and had not been cleared in reinspections before shipping, according to a warning letter from the agency.
The letter, issued to Diasol, of San Fernando, California, was based on visits by FDA inspectors in May and June to the company’s facility in Phillipsburg, New Jersey.
The letter pointed to two different batches of solution — identified as medical devices under FDA regulations — that were shipped despite laboratory tests recording excessive concentrations of sodium and a third batch shipped despite tests showing an excessive concentration of magnesium. It also flagged a shipment of solution for which the test results were dated after the shipment and initialed by a quality manager in San Fernando.
For other batches of solutions that failed tests, the letter said, no record was produced to show their final disposition.
The letter also found fault with poorly-fitting warehouse doors that could allow pests to enter and insulation sticking out of a gap between a wall and ceiling above an open bin of raw ingredients. Those problems apparently were corrected by Diasol in response to an initial Form 483 inspection report, the FDA said.
But the company’s responses to other findings were not adequate, the letter said.
For example, Diasol reported that it had updated its procedures to achieve “a significant reduction in the need for emergency release of untested product” by increasing stock on hand and anticipating customer needs. The FDA said that’s not good enough, and that no product should be released for sale until it has been tested to assure it meets specifications.