FDA Warning Letter: Lab Data Integrity disregarded

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

In July 2022, the U.S. FDA issued a Warning Letter to the U.S. American company "Jost Chemical Co." after having inspected its site in January 2022.

The significant violations of cGMP regulations for active pharmaceutical ingredients (APIs), which are mentioned in the Warning Letter, are listed as follows:

• "Failure of your quality unit to ensure that quality-related complaints are investigated and resolved, and failure to extend investigations to other batches that may have been associated with a specific failure or deviation."
  
• "Failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of API."
  
• "Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity, and failure to ensure laboratory data is complete and attributable."
  
• "Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to establish and follow written procedures for the operation and maintenance of your computerized systems."

Especially, the fourth observations mentioned in the Warning Letter is related to the lack of Laboratory Data Integrity. It is listed as an example that the firm failed to have "unique passwords for laboratory instruments used to generate analytical data for finished API products" and that the "analytical systems lacked controls to prevent users from deleting electronic data." The observed findings resulted in a long list of Data Integrity remediation activities and CAPA measurements requested.

Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA strongly recommends engaging a cGMP consultant to support the company in aligning their systems with cGMP requirements. Additionally, the U.S. FDA may refuse new applications or supplements listing the company as drug manufacturer until the site has addressed all observations and fully complies with cGMP requirements, which might be checked by a further inspection.

To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter Jost Chemical Co.