visionary contact lens – FDA Warning Letter, Feb 26, 2015

The FDA issued a Warning Letter to Visionary Contact Lens dba Visionary following an inspection from January 27 to February 26, 2015, which determined that the firm's rigid gas permeable contact lenses are adulterated. The manufacturing methods, facilities, or controls were found not to conform with the Quality System (QS) regulation, 21 CFR Part 820. The firm did not respond to the FDA 483 observations. Key violations include the failure to adequately validate software (CNC Lathe and MAS 90) used in production and quality systems (21 CFR 820.70(i)), and the failure to ensure equipment meets specified requirements and is appropriately installed, specifically lacking installation qualification for DAC Lathes #1 and #2 (21 CFR 820.70(g)). Additionally, the firm failed to establish procedures for verifying or validating corrective and preventive actions (CAPA) (21 CFR 820.100(a)(4)), and to establish and maintain CAPA procedures for investigating nonconformities and preventing recurrence (21 CFR 820.100(a)(2) and (a)(3)). Other deficiencies included the failure to establish procedures for and conduct quality audits for years 2011-2014 (21 CFR 820.22), and to adequately establish training procedures, with employees not trained in GMP, Quality, CAPA, and manufacturing equipment (21 CFR 820.25(b)). The FDA requires prompt corrective action within fifteen working days, including a plan to prevent recurrence and supporting documentation. Failure to comply may lead to regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts.