Company: Michigan Instruments Inc.
Product: Thumper Model 1007 Mechanical CPR System
Date: 3/23/04
You failed to perform or document the verification or validation of production process changes, such as the Inspiratory Time Test Specification, _____ on 12/17/2002 and the _____ software changes on 11/7/2000 (FDA-483 #11, c. and # 11, i) as required by 21 CFR 820.7(b).
You failed to validate the computer software, and all subsequent changes to this software, used in the operation of automated production machinery (FDA-483 # 18), as required by 21 CFR 820.70(i).
You failed to retain records 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, as required by 21 CFR 820.180(b). Specifically, you failed to retain portions of the Device Master Records, consisting of early versions of computer software, following revisions to that software (FDA-483 # 19).
You failed to establish and maintain procedures to ensure that sampling methods are adequate for their intended use. Specifically, you failed to document the procedures used to ensure the adequacy of the selected sampling plan used in the verification of the computer software used with the _____ machine (FDA-483 # 20) as required by 21 CFR 820.250(b).
You have failed to establish and follow procedures to monitor and control production processes (FDA-483 # 16) as required by 21 CFR 820,70(a)(2). For example, the 95 specifications listed in the “unapproved” computerized Process Control Data and the CNC Program Validation forms for the machining of the _____ have not been formally established into a monitoring and controlling procedure. This resulted in the failure to fully monitor and control production of three lots of _____ as listed in the referenced FDA-483 # 16 observation
You failed to maintain Device Master Records. Specifically, some of your Device Master Records (DMR’s) do not include or refer to the location of production and process specifications (FDA-483 # 14) as required by 21 CFR 820.181(b) For example, the portion of the DMR “approved” on 4/21/00 for producing the _____ on the _____ machine, lacks any specifications while an “unapproved” computer generated specification sheet lists 95 specifications.
However, it is our perception that the blank SIR and Flow Chart forms were designed for check in a box or short answers that are to be entered into the computerized system that provides very limited space for detailed answers. This appears to have caused inappropriate or insufficient detail in entries that failed to fully document the decision making process required to comply with the regulations. You need to make sure your records system provides instructions for and adequate space for entry of complete documentation of the decision process.
FDA District: Detroit District Office
