FDA WARNING_LETTER - Cosmed S.R.L. - May 10, 2011

An FDA inspection of Cosmed S.R.L. in Rome, Italy, from May 9-10, 2011, revealed that their Quark PFT Cardio Pulmonary System devices are misbranded under 21 U.S.C. § 352(t)(2) due to failure to furnish required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting). The inspection also identified nonconformances with quality system requirements under 21 U.S.C. § 351(h) and 21 CFR Part 820. Specifically, the firm failed to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17, lacking internal systems for timely event identification, standardized review, and complete report transmission, and failing to adequately document and maintain records. Additionally, the firm failed to adequately document corrective and preventive actions (CAPA) as required by 21 CFR 820.100(b), with CAPA reports missing final review/approval signatures or closure dates. Cosmed S.R.L.'s response dated May 25, 2011, was deemed inadequate. The revised MDR procedure was submitted in Italian without an English translation, and CAPA report documentation issues were not systemically addressed, with reports appearing to be signed/dated retrospectively. The FDA requires the firm to provide a written response within fifteen business days detailing specific corrective and preventive actions, including systemic changes, a timetable for completion, and English translations of all documentation. The letter emphasizes that these violations may indicate broader issues within the firm's quality management systems, and full compliance is expected.