FDA WARNING_LETTER - LC Medical Concepts, Inc - October 23, 2018

The FDA issued a Warning Letter to LC Medical Concepts, Inc. following an inspection from October 16-23, 2018, which identified significant violations of the Quality System Regulation (21 CFR Part 820) for their negative pressure wound therapy kits. The devices were deemed adulterated under section 501(h) of the Act.

Key violations include: 1. **Failure to adequately validate processes (21 CFR 820.75(a)):** Sterilization operations were not validated after moving manufacturing to a new facility with different conditions, and periodic dose audits were not conducted. The firm's response was inadequate as it did not address retrospective review of facility changes or revalidation plans. 2. **Failure to establish and maintain in-process product acceptance procedures (21 CFR 820.80(c)):** The firm did not comply with its own sampling plan for bag testing, and the sampling plan lacked a statistically valid rationale. The proposed new sampling plan also lacked statistical justification. 3. **Failure to routinely calibrate equipment (21 CFR 820.72(a)):** Equipment like the pull tester, calipers, and continuous band sealer were never calibrated, and no calibration schedule was in place. Calibration certificates provided did not indicate if equipment was calibrated for its range of use. 4. **Failure to verify or validate corrective and preventive actions (CAP