Piramal Pharma Limited's Morpeth facility in the UK has received seven observations after an inspection by the US Food and Drug Administration (US FDA), according to a regulatory filing.
The US FDA conducted the inspection at the facility from September 3-11, 2026, the company said in the filing.
"At the conclusion of the inspection, the USFDA issued a Form-483, with 7 observations. These observations are related to enhancement in our practices, procedures and documentation," Piramal Pharma stated.
The company said it is addressing these observations and preparing a detailed response for submission to the USFDA within the stipulated timeline.
Piramal Pharma added that it remains committed to maintaining the highest standards of compliance and will work closely with the agency to address all observations comprehensively.
Published on September 14, 2026
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