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# LC Medical Concepts Warned on Wound Kit Manufacturing
- URL: https://www.fdaweb.com/lc-medical-concepts-warned-on-wound-kit-manufacturing/
- Published: 2019-02-13T12:00:00.000Z
- Updated: 2026-09-15T01:03:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143377

FDA has sent LC Medical Concepts a 1/31-dated [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630928.htm?ref=fdaweb.com) after a 10/2018 inspection of the firm’s Rochester, NY, medical device operations found GMP concerns with the manufacturing of negative pressure wound therapy kits. The agency cited the company for failing to adequately validate with a high degree of assurance, a process whose results cannot be fully verified by subsequent inspection and test. For example, the company moved its manufacturing operations, but it did not assess the bioburden and particulate loads at the new site. “No assessment was done of the effects these changes may have on the sterilization process,” the letter said.

The letter also cited LC Medical for failing to ensure equipment used for manufacturing, inspection and testing is routinely calibrated. For example, the inspection found that equipment used to manufacture and test products was not calibrated according to a calibration schedule and that no calibration schedule is in place, it said.

Additionally, FDA said the company failed to verify or validate corrective and preventive actions (CAPA) to ensure the actions were effective and did not adversely affect finished devices. Specifically, FDA said two out of three CAPAs reviewed did not include verification or validation of CAPA effectiveness. “Both CAPAs were closed the same day as initiation, with no effectiveness check,” the letter said.