Warning Letter: Failure to develop adequate written procedures (ucm442577)

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Ofni Systems

1. Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically, Your procedures addressing corrective and preventive actions, “Procedures for Corrective and Preventive Action”, PCPA-00, dated10/5/10 and “Measurement and Analysis” procedure, MA-00, dated 10/5/10, are not adequate in that: a) Your procedures do not address:

1. How and how often each data source will be analyzed to identify existing and potential causes of nonconforming product.

2. Initiating a corrective and preventive action commensurate with the significance and risk of the nonconformity.

3. Verifying and validating corrective and preventive actions to ensure such action is effective and does not adversely affect the finished device.

4. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.


5. Failure to establish and maintain procedure for 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, a sticky note on the “Chaps” instructions sheet stating “No Longer Need F Velcro Lengths” is the only documentation for the change to receive the elastic with the Velcro already sown onto it. This design change did not go through your formal change control as required by “Change Control” procedure, CC-00, dated 10/5/10.

View the original warning letter.


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