Flowchem Pharma Private Limited
6 extracted findings · 4 model-assigned issue types
FDA source excerpt, selected passage
Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the intermediates and API beyond the official or other established specifications.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Failed to clean equipment and utensils to prevent contamination or carry-over of material that would alter API quality.
Supporting FDA text
Source excerpt · automated text-match checkFailure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the intermediates and API beyond the official or other established specifications.
Failed to ensure materials are handled and stored to prevent degradation, contamination, and cross-contamination.
Supporting FDA text
Source excerpt · automated text-match checkFailure to ensure that materials are handled and stored in a manner to prevent degradation, contamination, and cross-contamination.
Failed to establish an impurity profile for identified and unidentified impurities and ensure test procedures are scientifically sound.
Supporting FDA text
Source excerpt · automated text-match checkFailure to establish an impurity profile for identified and unidentified impurities and failure to ensure all test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity.
Failed to test the identity of each batch of incoming production material and appropriately qualify suppliers to rely upon their Certificate of Analysis.
Supporting FDA text
Source excerpt · automated text-match checkFailure to test the identity of each batch of incoming production material and appropriately qualify suppliers to rely upon their Certificate of Analysis.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide CAPA plan for routine operations management oversight of facilities and equipment.
- Provide comprehensive independent retrospective assessment of cleaning effectiveness.
- Provide CAPA plan based on retrospective assessment of cleaning program.
- Provide CAPA plan for operations management oversight and plans for sufficient storage space.
- Provide comprehensive independent assessment of laboratory practices and remediation plan.
- Provide retrospective review of all API lots released without appropriate impurity testing.
- Provide plan to address product quality or patient safety risks for OOS lots in U.S. distribution.
- Provide comprehensive independent review of material system and supplier qualification program.