Company:Daavlin Distribution Co.
Product:”3 Series Full-body Phototherapy Device” and other phototherapy units
Date: 9/22/04
Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR. 820.30(i). For example, design changes made to the 3 Series Full Body Phototherapy Device software to correct design defects were conducted without controlling the design process.
Failure to establish and implement procedures to verify and validate corrective and preventive action to ensure that such action is effective and does not adversely affect the finished product, as required by 21 CFR 820.100(a)(4). For example, corrective actions taken regarding updating the software provided with the 3 Series Full Body Phototherapy device were not fully verified and validated.
Failure to document all activities required under this section, and their results, as required by 21 CFR 820.100(b). There was no documentation to demonstrate that the software changes implemented with the 3 Series Full Body Phototherapy Device performed as intended. Also, there was no documentation to show that changes made to the software do not adversely affect the finished device.
FDA District: Cincinnati District Office
