Dynatronics Lands 15-Count 483 on CAPA, Procedural Problems

The GMP Letter
An FDA inspector’s determination that a single product at Dynatronics’ Ooltewah, Tenn., manufacturing plant fit Class II requirements triggered a 15-count Form 483 at the conclusion of a May 21-23 inspection, company President Kelwyn Cullimore Jr., told GMP.

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