Canton Laboratories Receives FDA Warning Letter for cGMP Violations for Data Integrity


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-17-2014 09:14

  
Some of the deviations cited included failure to perform laboratory testing of APIs to ensure conformance to specifications and to accurately report results on certificates of analysis with repect to microbial limits results on three API batches.The agency also noted a failure to maintain complete data dervied from laboratory tests conducted to ensure compliance with established specifications and standards, specifically citing a failure to prevent raw data from being deleted from an atomic absorption spectrophotometer used for elemental analysis testing. The agency also cited a failure by the company to ensure that equipment was adequately cleaned and the potential for cross-contamination of the APIs manufactured in this equipment. The agency also noted a failure by the company to ensure that APIs are produced according to pre-approved instructions and that batch production records include complete information pertaining to the production of each batch.
Additionally, several other observations were of particular concern, such as the firm's
  • Failure to properly investigate customer complaints.
  • Failure to properly investigate out-of-specification results.
  • Failure to follow the master validation plan for process validations or equipment calibrations.
  • Failure to provide adequate resources to the quality unit.
  • Failure of the quality unit to properly review production records and detect instances where testing was not performed to support the company’s certifications on certificates of analysis.
  • Failure to perform appropriate stability studies for product currently in the market.
  • Failure to establish an impurity profile for product currently in the market.
FDA is noted that these violatons raised serious concerns regarding the integrity, reliability and accuracy of the data generated and available at the company's facility. In response to the Warning Letter, FDA is requesting that the company provide a comprehensive evaluation of the extent of the deletion and destruction of records, a risk assessment regarding the potential impact on the quality of products,  a comprehensive corrective and preventive action plan, a detailed description of plans to implement a robust quality system, and a corrective action plan  that describes the company's commitment, procedures, actions, and controls to ensure data integrity.

Source: FDA
 

 

  

 

 

 

 

 

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