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 agency investigators 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.
The GMP Letter