Kansas City Devicemaker Written Up for Personnel Training, Design Reviews

August 29, 2019

The FDA slapped Southwest Technologies with a Form 483 over violations at its facility, including a lack of employee training and design reviews.

The agency, which inspected the company from March 11-20, found that the firm did not conduct or document design reviews and verification or validation activities for its ElastoGel sterile wound dressing and Stimulen collagen device products.

Personnel training was also an issue, as the facility’s training records did not show that employees were adequately trained in production and quality functions.

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