Warning letter: Failure to report a field correction to FDA (ucm581033)

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Ofni Systems

For example, your internal quality audit procedure, P715 “Internal Quality audits” (multiple version reviewed) is inadequate as the procedure allows your firm to utilize your customer audits conducted at your firm’s facility instead of your firm conducting its own internal audits at all times. It was noted during the review of your firm’s internal audit plans from 2012 – 2016, that instead of your firm conducting internal audits of all areas mentioned in your plans you counted the external audits conducted during this time frames as your “internal audit” of those areas… Additionally, in 2016, procedure P81 Software Validation for software used in processes was audited by [redacted]. However, your firm’s procedure does not explain how customer audits substitute your firm’s internal audits to ensure that the external customer audit will focus on the quality system being in compliance with the established quality system requirements…
Failure to submit any report required within 10‐working days of initiating a correction or removal, as required by 21 CFR Part 806.10. For example, your firm failed to report the following corrections or removals to FDA: a) field correction involving the replacement of a power supply related to REV7 of power supply 3359‐048 initiated March 22, 2012, and b) field correction involving software update (V1.2.5) for V‐Twin Analyzer with bar Code Reader Initiated February 1, 2016.

View the original warning letter.


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