Warning Letter: No CAPA Procedure (ucm 360143)

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Ofni Systems

These violations include, but are not limited to, the following:

Failure to establish and maintain adequate procedures for implementing corrective and preventive action and failure to document all activities under 21 CFR 820.100 and their results, as required by 21 CFR 820.100(a).

For example: Your Quality System Manual, dated 10/09/2012, Rev. A, Section 8.4 states that your firm has established procedures to document and analyze quality data from complaints, internal audits, supplier performance and non-conforming materials. Section 8.5 states that your firm has implemented a corrective and preventive action (CAPA) program to eliminate the cause of nonconformities in order to prevent recurrence. However, your firm does not have any written CAPA procedures. In addition, you have no records of analyzing quality system data obtained through sources such as complaints, internal audits, supplier performance and non-conforming materials, to determine if a CAPA action is required.

View the original warning letter.


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