Company: Con-Cise Lens Co.
Product: Rigid gas permeable contact lenses
Date: 9/19/03
Failure to perform and document validation of computer software that is used as part of production [21 CFR 820.70(i)]. Specifically, the software used to control the DAC DLL Series 3…has not been validated.
We note that seven items on the Form FDA 483 issued on June 24, 2003 were repeat observations from the previous Form FDA 483 issued February 11, 2002. We acknowledge receipt of your written response to the Form FDA 483 dated August 12, 2003. We have completed our review of your response and have determined that your response does not adequately address our concerns. Your response does not contain sufficient documentation of the supporting activities conducted by your firm to correct the deficiencies disclosed during our inspection. We also have two specific comments regarding your response to the Form FDA 483. The Oxycon lens that you manufacture is a Class II device subject to design controls [21 CFR 820.30]. Your response states that design may be addressed through calibration and verification activities. You also state that software validation for the lathe is performed continuously through production verification activities and calibrations. Calibration and manufacturing process verifications are not substitutes for design controls and/or software validation. You also stated that your firm will maintain in-process manufacturing records for 90 days. Please note that 21 CFR 820.180(b) specifies that all records required to be maintained under 21 CFR Part 820 are to be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.
FDA District: San Francisco District Office
