A C Cossor & Son (Surgical) Limited – FDA Warning Letter, Aug 16, 2012

The FDA issued a Warning Letter to A C Cossor & Son (Surgical) Limited following an August 2012 inspection in Harlow, UK, which found their Accoson Greenlight 300 Sphygmomanometer devices adulterated. The firm's manufacturing, packing, storage, or installation methods did not conform to the Quality System (QS) regulation (21 CFR Part 820). The company's August 28, 2012, response to the FDA 483 was deemed inadequate. Significant violations included systemic failures in establishing and maintaining procedures for corrective and preventive actions, complaint handling, and comprehensive design controls (design review, verification, validation, transfer, and change control). The firm also failed to maintain complete Design History Files, Device Master Records, and Device History Records. Deficiencies extended to supplier controls, production process monitoring, adequate sampling methods with statistical rationale, and document control. Additionally, devices were misbranded due to the absence of written Medical Device Reporting (MDR) procedures. The FDA noted the firm's proposed corrective actions lacked sufficient detail, retrospective review plans, and training commitments. The company must provide a detailed response within fifteen business days outlining corrections, preventive measures, and a timeline, with implications for contracts, device approvals, and foreign government certificates if unaddressed.