FDA 483 - OrthoGroup, Inc. - July 01, 2022

OrthoGroup, Inc. received an FDA Form 483 citing significant deficiencies across its quality system. The inspection revealed failures in establishing and implementing procedures for complaint handling, process validation, change control, device history records, purchasing controls, quality audits, management review, training, and document control. Additionally, the firm failed to maintain accessible and legible records, with some electronic records being corrupt.