Warning Letter: Use of electronic signatures to approve procedures (ucm446035)

“Failure to establish and maintain procedures to control all documents, as required by 21 CFR
820.40. For example, your firm failed to follow its Documentation Management procedure since it
used electronic signatures to approve numerous procedures. Your firm’s procedure states that
there are no currently-approved electronic signature systems implemented at your firm.”

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

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.

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Warning Letter: Mishandling and retrieval of electronic data (ucm393093)

Your firm failed to establish SOPs describing the handling and retrieval of electronic data. Handling of electronic data includes the security (e.g., audit trails) and statistical analysis of raw data. Specifically, the SOP for handling electronic data should describe a procedure for the archiving of multiple statistical analyses of the clinical pathology raw data with the study records. For Study [redacted], multiple sets of statistical analyses were maintained on the firm’s electronic server, and were not archived appropriately.

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Warning Letter: Nonconformance with 21 CFR Part 11 (m4105n)

• In addition, we further request details regarding steps your firm is taking to bring your electronic CGMP records into conformance with the requirements of 21 CFR Part 11; Electronic Records; Electronic Signatures.
• This inspection disclosed deficient controls in the laboratory electronic record keeping system, which is used for maintaining chromatography and audit trails.

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