Diora Kimya Sanayi ve Ticaret Limited Sirketi
5 extracted findings · 4 model-assigned issue types
FDA source excerpt, selected passage
Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Failed to perform identity testing on each component lot and relied on supplier COAs without validating supplier reliability.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals
Released drug product batches without performing required assay testing and transcribed supplier results to finished product COA.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to perform appropriate testing on your drug product prior to release for distribution. You stated to our investigator that assay testing was not performed on approximately (b)(4) batches of your including (b)(4) distributed to the U.S. market between 2022 and 2024.
Failed to complete process validation, cleaning validation, and equipment qualification for manufacturing.
Supporting FDA text
Source excerpt · automated text-match checkYou failed to adequately validate your production and process controls used in the manufacture of your drug product. You have not completed process validation and cleaning validation studies for your non-dedicated equipment.
Failed to maintain drug listing, resulting in product inactivation and misbranding.
Supporting FDA text
Source excerpt · automated text-match checkPersonal CARE Antibacterial Soap (NDC 72133-049) was not certified as required and was inactivated as of January 31st, 2024.
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
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide details of supplier qualification program and incoming testing for each component.
- Conduct analysis of retain samples or previously used components for quality attributes.
- Provide risk assessment or retrospective review of released products without testing.
- Provide supportive documentation and timelines for process validation and equipment qualification.
- Provide protocol-driven cleaning validation procedure.
- Conduct retrospective impact assessment of deficiencies on distributed products.
- Engage qualified consultant for comprehensive six-system CGMP audit.
- Ensure Personal CARE Antibacterial Soap is properly listed with FDA.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.