FDA Warns Clinicon for Lax Testing, Validation of Sterilization Processes

August 6, 2019

The FDA issued a warning letter to Clinicon for quality system lapses related to its SureProbe Class II sterile probe following an inspection of the firm’s Oceanside, California facility.

Clinicon’s sterile laser probes are used for the incision, excision, vaporization, ablation, coagulation or cauterization of soft tissues.

The April inspection revealed that the firm didn’t document validation of its packaging process, and there was no revalidation or reassessment of the sterilization process since 2015, the warning letter says.

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