FDA hits Piramal Pharma’s API plant in India with Form 483 for deficiencies
The FDA has issued an inspectional observation report to Piramal Pharma Limited’s active pharmaceutical ingredient (API) manufacturing facility in Navi Mumbai, India.
The agency’s inspection, conducted from Feb. 11 to 17, 2025, identified multiple deficiencies in the company’s quality control procedures, equipment maintenance, and record-keeping practices. The findings were documented in a Form 483, which outlines areas of non-compliance but does not represent a final regulatory action.
Among the most serious observations, the FDA cited failures in the facility’s quality control unit including a lack of documented procedures and unaddressed equipment leaks. During a walkthrough, inspectors observed a leaking vessel with no operator present and the company had no records detailing maintenance activities. Additionally, alarms on production equipment went unacknowledged for hours, with no investigation into the cause, raising concerns about process control and product integrity.
The agency also flagged inadequate investigations into production deviations. The facility had recurring issues with API batches getting stuck at various processing steps, yet failed to conduct timely risk assessments before continuing operations. In some cases, batches with unresolved deviations were reprocessed and released without full stability testing. Similar gaps were found in the handling of customer complaints, where the company failed to retrieve and test samples after reports of foreign particles in an API batch.
Another critical issue involved cleaning validation for shared manufacturing equipment. The FDA found the facility did not adequately demonstrate that equipment used for multiple products was free from contamination risks.
Inspectors also discovered improperly stored materials, including key starting materials requiring cold storage that had been transported at room temperature without assurance of temperature control.
Piramal Pharma has the opportunity to respond to the FDA’s findings and implement corrective actions. If the agency is not satisfied with the company’s response, further regulatory actions —including warning letters or import alerts — could follow.