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., said. All other products produced at the site are GMP-exempt, he said. Violations cited in the form included the absence of established quality audit procedures and failure to conduct any quality audits. Corrective and preventive action procedures did not define certain terms used or include investigative protocols, FDA inspectors wrote.
The GMP Letter