Ajanta Pharma has announced the completion of a US FDA inspection at its manufacturing facility located in Paithan, Maharashtra. The inspection, which took place from April 13, 2026, to April 21, 2026, resulted in the issuance of a Form-483 containing 5 observations. The company has committed to addressing these findings and responding to the regulatory body within the mandated timeframe.
Inspection Outcome at Paithan Plant
The manufacturing site in Paithan recently underwent a comprehensive assessment by the US Food and Drug Administration. The audit concluded on April 21, 2026, following an eight-day review process that began on April 13, 2026.
Next Steps for Compliance
As a result of the site visit, the regulators issued a Form-483 highlighting 5 specific observations regarding the facility’s operations. The management of Ajanta Pharma has confirmed that it is actively reviewing these observations. The company is currently preparing a detailed response plan and intends to submit its corrective actions to the US FDA within the stipulated timeline to ensure full compliance with international manufacturing standards.
Source: BSE
