MEDINVENTS NV – FDA Warning Letter, Jan 24, 2013

On January 21-24, 2013, an FDA inspection of Medinvents NV in Hasselt, Belgium, revealed violations concerning their Spirotome biopsy instruments, classified as medical devices. The firm's devices were deemed misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), due to failure to furnish required information under section 519, specifically regarding Medical Device Reporting (MDR). A key violation was the firm's failure to develop, maintain, and implement MDR procedures as required by 21 CFR Part 803.17, with the firm admitting to having no such procedures.

Additionally, the inspection identified significant quality system deficiencies under 21 CFR Part 820 (Quality System regulation). These included: 1. Failure to establish and maintain adequate procedures for production processes (21 CFR 820.70), with examples of undefined frequencies for critical process steps. 2. Failure to establish and maintain procedures for finished device acceptance (21 CFR 820.80(d)), as acceptance testing was not documented in procedures or device history records. 3. Failure to establish and maintain adequate procedures for controlling nonconforming product (21 CFR 820.90(a)), with no documentation of disposition or retesting for nonconforming products