Power Failures Land India-Based Cancer API Manufacturer a Form 483

Regulatory NewsRegulatory News | 23 August 2019 |  By 

Following a five-day inspection last month, the US Food and Drug Administration (FDA) sent a Form 483 to active pharmaceutical ingredient (API) manufacturer Shilpa Medicare Limited after the agency uncovered long-lasting power failures at the site.

“During the walkthrough on 24 July 2019, three power failures occurred within the facility during a 15-minute interval and a back-up generator did not resume power,” FDA investigator Yvins Dezan wrote. And while reviewing audit trails for two stability chambers, Dezan said it was noted that the facility “frequently loses power, sometimes for over 8 hours.”

Shilpa manufactures generic versions of cancer treatments for the US market, noting in May that it won approval from FDA to manufacture generic versions of the cancer drugs docetaxel and zoledronic acid. The company also recently won approval from FDA to manufacture generic busulfan injections to treat chronic myelogenous leukemia.

But FDA found that the firm “has not maintained any records for power failures that occurred within the manufacturing areas or the quality control (QC) lab, and has not conducted any investigation or assessment regarding the impact of the power failures to in-process product, QC Laboratory equipment calibration and on-going testing.”

The firm was also found to have lacked the appropriate equipment. The Form 483 says: “No documentation or assessment of what replacement equipment will be used to make this API was performed until the second day (23 July 2019) of the inspection. In addition, no notification of these changes was sent to the agency, the existing process flowchart for the product was not updated, and there is no documentation substantiating the decommission of the equipment.”

Another Shilpa Medicare site in Mahabubnagar, India received multiple Form 483s in 2017.

Form 483


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