Warning Letter: Failure to follow SOP/Lack of controls (ucm401451)

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Ofni Systems

1. Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.

Your firm lacked accurate raw laboratory data records for API batches shipped by your firm. The inspection revealed that batch samples were retested until acceptable results were obtained. In addition, your quality control (QC) laboratory failed to include complete data on QC testing sheets. Failing or otherwise atypical results were not included in the official laboratory control records, not reported, and not investigated.

Your firm’s response to the Form FDA-483 acknowledges the deficiencies regarding data integrity observed during this inspection. Nevertheless, your firm’s health hazard evaluation “Drug Safety Analysis” conducted in response to the Form FDA-483 concluded that there was no effect on product quality or patient safety. However, this evaluation was based on unreliable and incomplete data, as undesired records appear to be excluded. For instance, your report failed to include all of the batches tested, and did not list all of the customers you notified other than Apotex, Inc. Your response to the previous 2010 inspectional findings stated that “We are confident that … SOPs covering OOS … and Deviation … will provide the necessary control over the system to ensure consistent application and on-going compliance to this requirement.” However, you clearly failed to detect and investigate the inaccurate data found by our investigators during this recent inspection.

 

View the original warning letter.


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