Lab Data Integrity issues by US FDA

The significant violations of CGMP regulations for finished products, which are mentioned in the Warning Letter, are listed as follows:

"Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a))."
"Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b))."
"Your firm failed to establish the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e))."
Especially, the second observation mentioned in the Warning Letter is related to the lack of Laboratory Data Integrity. It is listed as an example that the firm failed to have "appropriate controls to assure the integrity of electronic test data, such as an audit trail and defined user access levels".

The observed findings resulted in a long list of Data Integrity remediation activities and CAPA measurements requested.

Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA placed the company on import alert. Additionally, the U.S. FDA may refuse new applications or supplements listing the company as manufacturer until the site has addressed all observations and fully complies with CGMP requirements, which might be checked by a further inspection.

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