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FDA Details Observations At Stricken Jubilant Roorkee Facility

List Of Seven Form 483 Observations of CGMP Deficiencies Published

 
• By Dean Rudge

Indian firm Jubilant Pharmova demonstrated a host of deficiencies at its manufacturing facility in Roorkee, including for cleanliness, laboratory controls, control procedures and data management, according to a US FDA Form 483 that has just been unveiled.

FDA entrance sign 2016
The FDA inspection took place in March 2021 • Source: Shutterstock

A pen cap being contained in a tablet bottle was among numerous Form 483 good manufacturing practice deficiencies observed by the US Food and Drug Administration following an inspection at Jubilant Pharmova’s import alert-hit Roorkee manufacturing facility in Haridwar, Uttarakhand, earlier this year.

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