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Pharmaceuticals / Inspections and Audits

FDA Cites Indian API Maker for Procedural Failures

Feb. 11, 2019
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The FDA hit Indian API manufacturer Malladi Drugs and Pharmaceuticals with an extensive Form 483 for multiple violations at its facility in Gajulamandyam, Andhra Pradesh.

During an Oct. 1-9, 2018 inspection, the agency found that the firm failed to validate cleaning procedures for non-dedicated manufacturing blocks and clean rooms where it produced intermediates and APIs marketed in the United States.

The facility failed to conduct cleaning validations for all non-dedicated equipment using the worst-case drug product made on them. “The adequacy of cleaning of the non-dedicated manufacturing blocks are not verified through recovery studies [or] any other scientific means to ensure the prevention of cross-contamination,” the investigator said.

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