Intas Pharma Facility in India Hit With Form-483
FDA has cited major quality control and data integrity concerns at an Indian manufacturing facility operated by Intas Pharmaceuticals, including repeated stability failures tied to a drug product distributed in the U.S. and allegations that electronic batch records were altered without proper documentation. The findings were detailed in a just-posted Form FDA 483 that was issued following an inspection conducted last September at the company’s drug manufacturing site in Dehradun, Uttarakhand, India.
FDA investigators said the company failed to adequately investigate unexplained discrepancies and out-of-specification (OOS) results involving a tablet product sold in the U.S. market. According to the inspection report, the firm repeatedly extended the product’s shelf life despite insufficient stability data supporting those changes. Investigators said the company also modified the shelf life multiple times through internal change controls before later obtaining an OOS assay result during annual stability testing for one batch. FDA said the company ultimately confirmed the result as valid and recalled the affected batch.
The agency criticized the company’s broader impact assessment as inadequate, noting that dozens of batches of various strengths of the same product had been distributed to the U.S. market since 1/2024. FDA investigators also stated that the company had recorded about 22 confirmed OOS stability failures involving the product since 5/2023.
The inspection report also raised concerns over the company’s handling of laboratory investigations. In one case, an assay failure for a tablet batch manufactured in 2023 was invalidated after the company attributed the issue to analyst error during solution preparation. FDA investigators wrote that there was no evidence the analyst had deviated from the written analytical method and noted that the company issued retraining but did not initiate corrective and preventive actions.
Separately, FDA investigators documented what they described as serious deficiencies involving electronic records and data governance practices. According to the report, signed electronic batch records were modified through communications with the software vendor without corresponding quality management system events or deviations being opened. Investigators alleged that some changes involved replacing employee electronic signatures in completed production records while retaining the original timestamps.
FDA said certain communications requesting modifications to official GMP records were conducted through shared group email accounts with common passwords. Investigators also alleged that some emails associated with those requests were later deleted.
The agency further stated that audit trails in the company’s electronic systems did not capture certain changes made to batch records and document control records, raising concerns about the reliability and integrity of the systems used for GMP documentation. Among the examples cited, FDA described instances in which quality assurance employees allegedly directed a software vendor by email to alter operational details in completed batch records, including signature times, material weights, tablet counts and other manufacturing parameters across multiple product batches.