Company: Morton Grove Pharmaceuticals, Inc.
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)). Data Integrity Remediation Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. We acknowledge that you are using a consultant to audit your operation and assist in meeting FDA requirements. In response to this letter, provide the following. A. A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include: A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude. Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party. An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity lapses. A comprehensive retrospective evaluation of the nature of the testing data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity lapses. Our investigators observed that information technology (IT) staff at your facility share usernames and passwords to access your electronic storage system for (b)(4) data. Your IT staff can delete or change directories and files without identifying individuals making changes.After a previous inspection in which FDA observed similar deficiencies, you committed to eliminate these and other data integrity vulnerabilities.
In response to this letter: Provide your detailed plan to ensure that each current and future employee will have a unique username and password to allow traceability of changes to electronic data back to specific authorized personnel. Describe the specific changes made to your software and electronic systems to ensure the effectiveness of your corrective actions. Include a detailed description of the role of your quality unit to ensure that the corrections are appropriately implemented and sustainable.
FDA District: Chicago District Office