news

Emcure Pharmaceuticals receives warning letter from FDA

1
SHARES

A warning letter has been sent to Emcure Pharmaceuticals after an FDA facility inspection found that the company did not adequately investigate sterility failures.

The US Food and Drug Administration (FDA) has sent a warning letter to Emcure Pharmaceuticals after an inspection of the company’s facility in Maharashtra, India. The Agency found the company had neglected to thoroughly test sterility failures during an inspection that took place in February.

 

ACCESS your FREE COPY

 


This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.

Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.

What you’ll discover:

  • Key trends shaping the pharmaceutical formulation sector
  • Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
  • Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
  • And more!

Don’t miss your chance to access this exclusive report ! Access now – it’s free

The letter, which was addressed to Mr Satish Mehta, CEO of Emcure Pharmaceuticals, states that the company did not adequately investigate the failures that were obtained during routine batch release testing.

“According to your sterility failure investigations, the most probable root cause for both events was laboratory error,” the letter says. “Your firm’s investigations substantially addressed the potential for microbial contamination during sterility testing, but de-emphasised potential manufacturing causes.

Your sterility failure investigations lacked sufficient data to support its conclusions.”

The FDA further states within the letter that the sterility issues found at the company were repeat violations from a previous inspection that took place on 7 August: “In a previous inspection… FDA cited similar current Good Manufacturing Practice (cGMP) observations in which you inadequately performed microbiological investigations. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

The letter concludes that the FDA may withhold approval of any new applications or supplements listing Emcure Pharmaceuticals as a drug manufacturer until it “correct[s] all violations completely and we confirm your compliance with cGMP.”

Emcure Pharmaceuticals has 15 working days to respond to the warning letter in which is has to specify what it has done since the FDA’s inspection to correct its violations and to prevent their recurrence.

One response to “Emcure Pharmaceuticals receives warning letter from FDA”

  1. fda prior notice says:

    Great point! The importance of FDA prior notice can’t be overstated, especially when it comes to ensuring public safety and smooth international trade. Timely and accurate submission helps avoid delays and keeps supply chains efficient. It’s a critical step for compliance in food and product safety regulations.

Leave a Reply

Your email address will not be published. Required fields are marked *

Share via
Share via