Audit Trail in the Centre of an FDA Warning Letter

On April 15, 2020, the FDA issued a Warning Letter to the Indian company Shriram Institute for Industrial Research - based on an inspection in October 2019. In addition to other problems issues with audit trails in the laboratory and their inadequate response led to this Warning Letter. FDA Warning Letters always refer to the corresponding chapters of 21 CFR Part 211.

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(a))


The company serves as a contract testing laboratory, which analyses both active ingredients and pharmaceuticals. During the inspection, the FDA inspector noticed that the audit trail on HPLC units was switched on only a few days before the inspection. This was confirmed by the employee during the inspection. The central problem here; it is a repeated observation at this company. Already during an inspection in 2016 this point occurred, and the company gave a written commitment to install audit trails.

The integrity of laboratory data is crucial for drug quality decision-making. It is important for the FDA to maintain strict control over electronic GMP data to ensure that all additions, deletions, and changes to information in the electronic records are authorized and documented.

Response of the Company

In the company's reply, the only remedy was to appoint an equipment technician to carry out routine inspections to ensure the proper performance of the equipment. This response was not sufficient for the FDA. The FDA lacked a description of specific controls that would be implemented to ensure that audit trails remained active and the integrity of data was not compromised.

What does the FDA expect when answering this Warning Letter

A comprehensive and independent assessment of laboratory practices, procedures, methods, equipment, documentation and analyst competence is required. On the basis of this assessment, a detailed plan for remedial action and evaluation of the effectiveness of the laboratory system is supposed to be established.

Source: Warning Letter to Shriram Institute for Industrial Research

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