FDA Warns India-based Indoco for Data Integrity Concerns

The FDA hit Indoco Remedies with a warning letter for significant CGMP violations related to data integrity following an inspection of its production facility in Goa, India.

A Jan. 17-25 inspection revealed the firm failed to properly report compression machine process control values in its batch production records for tablets intended to be sold in the U.S. Inspectors found mismatches between handwritten values in the batch records and the values recorded digitally by the compression machine.

The firm’s initial response to the mismatched data was insufficient, the agency said, calling the company out for failing to commit to a “comprehensive retrospective evaluation” of data integrity in its manufacturing operations.