Quality system violations at Alere’s San Diego, Calif., manufacturing facility have landed the healthcare management company a warning letter.
The Oct. 9 letter by the FDA’s Los Angeles district office follows a seven-observation Form 483 issued at the conclusion of a March 12 to June 27 inspection.
Alere’s Triage cardiac marker devices are adulterated due to a variety of deviations from good manufacturing practices, the FDA said. For instance, the company did not ensure manufacturing processes that could not be verified through testing were thoroughly validated, inspectors said. The company’s code chips racked up 37 complaints in two-and-a-half years — at least 23 of which appeared tied to a failure to validate the chips’ programming before they were put in devices, the letter states.
In addition, Alere did not define its design and document output practices in ways that allow the company to check finished designs against the design input. Some products did not meet standards described on packaging, the agency said.
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