FDA WARNING_LETTER - Owen Mumford USA, Inc. - December 12, 2013

On December 3-12, 2013, an FDA inspection of Owen Mumford USA, Inc. in Marietta, Georgia, revealed that the firm, which packages and repackages medical devices including hypodermic needles, was in violation of the Federal Food, Drug, and Cosmetic Act. The firm's devices were deemed misbranded under section 502(t)(2) for failing to furnish required material or information under section 519 and 21 CFR Part 803 - Medical Device Reporting (MDR).

The primary violation cited was the failure to adequately develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. Specific deficiencies in their "MDR Decision/Submission Tree Work Instruction" (Doc #OMQA07B.W002, Revision 00) included: 1. Lack of internal systems for timely and effective identification, communication, and evaluation of events subject to MDR, specifically omitting definitions for key terms like "reportable event," "serious injury," and "malfunction." 2. Absence of a standardized review process for determining reportability, including no instructions for complete event investigations, unclear decision-making authority for reporting, and no guidance on timely evaluation of event information. 3. Failure to establish internal systems for timely transmission of complete medical device reports, omitting circumstances for submitting various report types (30-