LC Medical Concepts’ sterilization operations were not adequately validated to demonstrate sterility of its wound therapy kits, an Oct. 16-23, 2018, FDA inspection of the devicemaker’s Rochester, New York, facility revealed.

The firm’s manufacturing plant was moved, and manufacturing conditions had changed but no assessment was conducted on the effects of these changes on the sterilization process, the FDA said.

The FDA was not satisfied with the firm’s Nov. 12, 2018 response to the Form 483 and it issued a Jan. 31 warning letter.

The warning letter said the firm’s response did not include a retrospective review of the facility changes to assess the need for revalidation.