FDA EIR - Echosens - February 01, 2017

An FDA inspection of Echosens, a medical device manufacturer based in Paris, France, took place from January 30 to February 1, 2017. This initial inspection, conducted under C.P. 7382.845 for Medical Device Manufacturers and utilizing the Quality System Inspection Technique (QSIT), focused on the company's Class II Diagnostic Ultrasonic Transducers. The inspection revealed significant deficiencies, resulting in the issuance of an FDA-483, Inspectional Observations. The main violations identified were: 1) Inadequate Corrective and Preventive Action (CAPA) Procedures (21 CFR 820.100(a)), specifically lacking requirements for investigating nonconformities, identifying corrective actions, validating effectiveness, documenting changes, and disseminating crucial quality information. 2) Deficient Complaint Handling (21 CFR 820.198(a)), where the written procedure did not reflect the actual process, and complaint records lacked documented investigations. 3) Insufficient Internal Audits (21 CFR 820.22), as the company failed to audit its entire quality system within the required three-year cycle as per its own procedures. At the conclusion, Echosens management acknowledged these findings and committed to submitting a written response to the FDA detailing the corrective actions they would implement.