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Document Management
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records are instituted by authorized personnel. Biocon Sdn Bhd |
27 Sep 2024 | Normal | Justification: Document management issues are highlighted by the lack of control over General Format documents used in critical processes. Excerpt: General Format documents not controlled or reconciled; forms can attach data printouts for DEV/CAPA investigations. View Details |
| Records associated with the API distribution were not readily available Aarti Drugs Limited |
20 Sep 2024 | Normal | Justification: The missing records are a direct result of poor document management practices, impacting data completeness and regulatory obligations. Excerpt: Your Site Head acknowledged the missing data from the shared API list and promised to provide updated list. View Details |
| Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the previous six month period. Annovex Pharma, Inc. |
06 Sep 2024 | Normal | Justification: Document Management is crucial as the failure stems from not managing and submitting the report properly. Excerpt: Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the previous six month period. View Details |
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Granules India Limited |
06 Sep 2024 | Normal | Justification: Faulty document management is evident by unauthorized disposal of critical GMP documents as per observation. Excerpt: We observed three (3) trucks full of scrap materials...revealed presence of large number of torn pieces of GMP documents. View Details |
| The responsibilities and procedures applicable to the quality control unit are not Granules India Limited |
06 Sep 2024 | Normal | Justification: Document Management is fundamentally linked owing to the mishandling and unauthorized disposal of critical GMP documents. Excerpt: Lacks oversight on the control and management of GMP documents... three trucks full of scrap materials... torn pieces of GMP documents... View Details |
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