FDA 483 - Intas Pharmaceuticals Limited - September 17, 2025

During an inspection from September 8-17, 2025, Intas Pharmaceuticals Limited, a drug product manufacturer in Dehradun, India, received an FDA Form 483 detailing significant observations concerning its adherence to Good Manufacturing Practices. Key issues included a failure to thoroughly investigate discrepancies and ensure data integrity. The firm inadequately supported drug product shelf-life with stability data, leading to multiple adjustments and Out-of-Specification (OOS) results, impacting numerous distributed batches. One OOS result was invalidly attributed to an analyst error without sufficient evidence, and no corrective action was initiated.

The quality control unit exhibited critical deficiencies in data integrity. Signed electronic batch records were modified without proper Quality Management System (QMS) events or an audit trail, often through direct communication with a software vendor. The company lacked policies to maintain these critical electronic communications, and several relevant emails were found deleted. Furthermore, an approved Standard Operating Procedure's effective date was changed electronically without an audit trail, compromising record reliability. The use of shared group email IDs for official GMP business further exacerbated these issues.

Additionally, batch production and control records were incomplete, notably with a missing batch record for a cancelled manufacturing batch, for which no deviation was raised. These observations highlight serious concerns regarding data integrity, quality system oversight, and adherence to regulatory requirements. Intas Pharmaceuticals Limited must provide a comprehensive response detailing corrective actions to address these deficiencies.