FDA 483 - D. O. Weaver and Company - May 12, 2023

D. O. Weaver and Company, a medical device manufacturer in Aurora, CO, received a Form FDA 483 with two significant observations. The firm failed to adequately validate processes for its Nuprep® and Ten20® products, specifically regarding the range of process parameters and statistical rationale for sample sizes. Additionally, the company's investigation records for MDR reportable complaints were found to be deficient, with insufficient follow-up attempts and a failure to report an adverse event.