When it comes to maintaining clean equipment for making medicines, one drug maker recently danced around the issue.

During an inspection of a Centurion Laboratories facility in India last October, a Food and Drug Administration investigator noticed a variety of troubling manufacturing problems. These included a failure to follow written procedures for cleaning and maintaining equipment.

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  • Then they are out of compliance with Part 11 along with the common sense items that they overlooked as well.

  • At least the company did not truly ‘dance around the truth’ when it came to the cleaning issues. The forms torn to “avoid confusing the investigator,” perhaps not so much?

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