Warning Letter: Failure to demonstrate validation (ucm251784)

Your firm provided “Device Inspection Record” dated October 11, 2007, and Report No. SV-25 Rev 0 “Software Validation Report” dated May 30, 2008 as the only two design validations conducted for the LVT100 design project.

• Device Inspection Record” and Report No. SV-25 Rev 0 do not reference the serial numbers of the LVT100s used in the validation activities. Therefore, your firm was unable to demonstrate that these design validation activities were performed on initial production units, lots, or batches, or their equivalents. Although the person responsible stated that initial production units were used in both validations, DHRs were not maintained.
• Your firm did not develop any validation protocols for “Device Inspection Record” and Report No. SV-25 Rev 0.

View the original warning letter.