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Audit Management
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Your internal audit is not effective to verify compliance with the principles of CGMP for APIs. Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: Audit Management is directly linked as the observation highlights deficiencies in the audit execution and auditor qualifications. Excerpt: Your firm’s internal audit is not robust and are all preannounced audits based on a predefined checklist. View Details |
| Computerized systems lack controls and review of electronic data to prevent omissions in data. Biocon Biologics Limited |
26 Jul 2024 | Normal | Justification: The failure to have detailed, software-specific audit procedures directly affects the completeness and accuracy of data reviews. Excerpt: Audit trail review procedures for production software are general and do not contain instructions specific to the different software to ensure a thorough review of raw data. View Details |
| Records associated with drug product production and control and within the retention period for such records, were not made readily available for authorized inspection. Mylan Laboratories Limited |
24 May 2024 | Normal | Justification: Audit Management pertains to the observation due to complications in provision and management of audit-related documents. Excerpt: These events and interactions detailed in this section introduced a delay in our ability to perform the remainder of the inspection in a timely and effective manner. View Details |
| Input to and output from the computer and records or data are not checked for accuracy. Eugia Steriles Private Limited |
05 Apr 2024 | Normal | Justification: Audit management deficiencies are evident from missing findings in the audit trail reviews. Excerpt: These findings were not included in your executed audit trail review performed for the data obtained during October, November 2022 and March 2023. View Details |
| Failure to maintain a backup file of data entered into the computer or related system Eugia SEZ Private Limited |
29 Feb 2024 | Normal | Justification: The reliance on manual logs and the inability to verify them electronically directly points to deficiencies in the audit management process. Excerpt: These records are managed using manual logs that could not be verified electronically during the inspection. View Details |
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