FDA Warns Diagnostics Company for Validation, Testing Issues

MP Biomedicals’ diagnostics division received a warning letter citing a number of validation issues involving its in vitro diagnostics.

The company’s Solon, Ohio, facility averaged out-of-specification (OOS) values or allowed the removal of one OOS value during finished device testing, according to the warning letter. As a result, the test records for 17 of 30 phenylalanine kits reviewed by an FDA inspector had one of three values out of specification.

MP said it is resolving all the issues raised in the warning letter.
The GMP Letter