Piramal Pharma Limited said the US FDA inspected its Lexington unit from 3 to 10 December 2025. The inspection ended with a Form 483 carrying four observations. The company stated that these relate to procedure updates and are classified as Voluntary Action Indicated.
Source: Piramal Pharma Limited Press Release (NSE Exchange Filings) | Published on Dec 11, 2025
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As quoted in the press release from Piramal Pharma Limited and its news (NSE Exchange Filings), the company informed stock exchanges about a US FDA inspection at its Lexington facility in Kentucky, United States. The inspection was a general Good Manufacturing Practices review. It started on 3 December 2025 and ended on 10 December 2025. The disclosure was made under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
The filing confirms that the inspection covered routine GMP compliance at the manufacturing site.
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The US FDA inspected the Lexington facility from 3 to 10 December 2025
The inspection ended with a Form 483 containing four observations.
The deficiencies cited may be rectified through improved procedures
It is classified as Voluntary Action Indicated
At the end of the inspection, the US FDA issued a Form 483.The form listed four observations.
The company stated that these observations relate to enhancements in procedures followed at the facility. The classification of the observations was stated as Voluntary Action Indicated.
The update reports the inspection outcome as recorded at the close of the review.
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The disclosure states that Piramal Pharma Limited is preparing a detailed response to the observations. The response will be submitted to the US FDA within the required timelines. The filing records confirmed the information available at the end of the inspection. It does not include forecasts, assumptions, or outcomes beyond the stated facts.
Such disclosures form part of routine regulatory reporting for overseas inspections.
Particular | Details |
Company | Piramal Pharma Limited |
Facility | Lexington, Kentucky, USA |
Regulator | US Food and Drug Administration |
Inspection Type | General GMP Inspection |
Inspection Dates | 3–10 December 2025 |
Observations | Four |
Classification | Voluntary Action Indicated |
Piramal Pharma share price data showed movement on the day of the disclosure. As per NSE data on 11 December 2025 at 15:30 PM IST, the Piramal Pharma share price stood at ₹172.10.
The stock gained ₹1.11, or 0.65%, during the session. It opened at ₹170.90 and touched an intraday high of ₹173.62. The day’s low was ₹169.58.
The previous close was ₹170.99. The volume weighted average price for the session stood at ₹171.74.
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