Rossmax International Ltd – FDA Warning Letter, Nov 1, 2007

The FDA issued a Warning Letter to Rossmax International Ltd. on May 27, 2008, following inspections from October 22 to November 1, 2007, and a previous Warning Letter on March 28, 2008. The firm's April 18, 2008, response was deemed inadequate in addressing several deficiencies. Key violations include inadequate process validation procedures (21 CFR 820.75), insufficient Corrective and Preventive Action (CAPA) investigation reports lacking actual corrective/preventive actions, and inadequate testing to ensure a heat tunnel alarm system's suitability. Furthermore, the firm's purchasing control procedures (21 CFR 820.50) were insufficient, specifically regarding agreements with US customers/agents, Device Master Record/Device History Record review, and clarifying roles in lot release/distribution. Design control procedures (21 CFR 820.30) were also found inadequate, missing critical elements like planning, input, output, review, verification, validation, transfer, changes, and a Design History File. Finally, document control procedures (21 CFR 820.40) were deficient regarding the use of ink stamps for review and approval. Rossmax must provide a written response within 30 days detailing new or revised procedures and documentation to address these serious quality system deficiencies.