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 warning letter listedfour significant areas:
- “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.”
I offer them the above clip as a good mini-training. I recently watched the show, and my wife thought I was going to have several heart attacks.
In a serious nature, please do not short your efforts in data integrity.