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.
The agency required the manufacturer to provide a summary of its documented assessment of the product and the process changes for the appropriateness of the sterilization process as well as plans to revalidate the sterilization process, including a protocol and acceptance criteria.
Not only did the firm not comply with its own sampling plan, but it failed to ensure that manufacturing equipment was routinely calibrated. It also failed to verify that corrective and preventive actions were effective and that they didn’t adversely affect the finished product.
The warning letter noted that two out of three CAPAs did not include verification or validation of CAPA effectiveness, and both CAPAs were closed on the same day they were initiated.
Read the LC Medical Concepts Form 483 here: www.fdanews.com/04-11-19-lcmedicalconceptsinc483.pdf.
Read the warning letter here: www.fdanews.com/04-11-19-LCMedicalConceptsWL.pdf.