So-Low Supplier, Quality Problems Behind FDA Form 483

So-Low Environmental Equipment, based in Cincinnati, lacks written or verbal quality agreements with its suppliers, an April 17 FDA Form 483 says.

“There is no agreement that states suppliers will notify So-Low of changes in the product or service being provided,” according to the form. Further, the company’s management told the FDA investigator it would be difficult to come up with a complete list of suppliers.

Meanwhile, So-Low does not document instances of incorrect or damaged materials from suppliers.
And the company failed to follow its nonconforming product procedure. Instead of recording nonconformances on the appropriate form, employees “fill out a ‘problem unit’ form and stick it to the side of the fridge until the problem is resolved,” the form says. Those are filed without being tracked.

In a repeat observation, the company’s management did not review its quality system, as its procedures require. The only documented meeting since a 2009 FDA inspection was on April 8 — one day before the most recent FDA inspection. Additional repeat observations in the 14-count form include lack of written MDR procedures, lack of written procedures for inspection of incoming product, lack of adequate written procedures for the processes used to make medical freezers, complaint file issues and CAPA documentation shortcomings.

The company declined to comment on the form.

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