FDA MEDICAL DEVICE


FDA Medical Device Templates.

FDA Medical Device templates taken from 483’s and FDA warning letters. Some are so basic, it is alarming that there are persons in the industry so poorly informed. Others are pure complacency, with a drop of arrogance mixed in.

  • FDA medical devices audits were not conducted at sufficient regular intervals as prescribed by internal procedure to verify that the quality system is effective in fulfilling the quality system objectives [21 C.F.R. 820.22]. Specifically, the Internal medical device procedure states the audit schedule is based on ensuring all elements of ISO 13485, IVD Directive and CMDCAS ISO 13485 are audited.
  • Individuals who conduct quality audits have direct responsibility for the matters being audited, in violation of 21 C.F.R. 820.22. Specifically, one [redacted] of the individuals who audited manufacturing on 3/6/06 had direct responsibility over the area he audited.


     Medical Devices Validation.

    Medical device validation Have you have failed to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).

    You have failed 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).

    You have failed to adequately establish and maintain the procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by FDA Medical Devices validation legislation.

    You have failed to review, evaluate, and investigate any medical device  complaint involving the possible failure of a device to meet any of its specifications, as required by 21 CFR 820.198(c).


     Medical Device Qualification

  • Medical Device qualification procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product [21 CFR 211.110(a)]. FDA Warning Letters 14.
  • During the inspection, the FDA investigator asked how the bulk medical device samples can be considered to be representative of the complete manufacturing process, including the filling operation. Our investigator was told that sampling procedure is used because First Priority has performed process validation testing on all products. However, our inspection revealed that none of the process validation studies reviewed, particularly for suspension and powder products, established a hold time between compounding and filling. FDA Warning Letters 15.

    Individuals who conduct medical device qualification quality audits have direct responsibility for the matters being audited, in violation of 21 C.F.R. 820.22. Specifically, one [redacted] of the individuals who audited manufacturing on 3/6/06 had direct responsibility over the area he audited.



      FDA MEDICAL DEVICE



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