Shares of Piramal Pharma fell over 3% in intraday trade on Tuesday, September 15, after the company reported seven observations from a USFDA inspection of its Morpeth facility in the UK.
The USFDA issued a Form 483 following a Good Manufacturing Practices (GMP) inspection of the facility, Piramal Pharma said in a stock exchange filing on Monday.
This extended the stock’s losing streak to a fourth consecutive session.
The US FDA conducted a GMP inspection of Piramal Pharma’s Morpeth, UK facility from September 3 to September 11, 2026, the company said in a stock exchange filing on Monday, September 14.
The inspection concluded with the US FDA issuing a Form 483 containing seven observations. Piramal Pharma said the observations relate to enhancements in its practices, procedures and documentation.
The company said it would address all seven observations and prepare a detailed response for submission to the USFDA within the stipulated timeline. It added that it remained committed to maintaining compliance standards and would work closely with the agency to address the observations.
A Form 483 is a list of observations made during an inspection, issued by USFDA inspectors upon completion. Inspectors communicate and explain these observations to the supplier during a closing conference. However, a Form 483 does not represent a final FDA determination regarding a facility’s GMP compliance.
After a Form 483 is issued, the company is given 15 days to submit its response to the USFDA, explaining what steps it will take to resolve the observations.
The company’s shares have risen over 21% since the beginning of the year, while rising more than 1% over the trailing 12 months.
The stock was trading at a 12.4% discount to its 52-week high of ₹231.93, which it had achieved during trade on September 8.
According to the latest shareholding data, more than 64.72% of the company’s shares were held by the public, while 34.8% was held by promoters.
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