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Pharmaceuticals / Inspections and Audits

FDA Cites Indian API Maker for Procedural Failures

Feb. 11, 2019

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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