The FDA chastised another Indian drugmaker for poor quality, this time warning active pharmaceutical ingredient manufacturer Smruthi Organics for not protecting raw data and blending out-of-specification batches of API with conforming batches.
The criticism comes in a warning letter published March 25, and follows a Form 483 that stemmed from an October 2013 inspection of Smruthi’s Solapur, India facility. The company was put on import alert earlier this month.
Investigators were deeply troubled by various quality issues at the plant. A February 2013 inspection conducted by the European Directorate for Quality of Medicines found Smruthi blending out-of-specification API batches with passing batches.
When the FDA investigator followed up on this observation during the October inspection, a company official said the relevant records had been destroyed. However, Smruthi noted in its response to the Form 483 that the records weren’t destroyed and that there was a miscommunication.
The FDA requested those records, a full accounting of all blended batches and an update on the company’s own investigation.
Investigators were also alarmed that standard operating procedures don’t include instructions for employees to retain electronic raw data, and that personnel used incomplete raw data to validate the test method for APIs.
The FDA asked Smruthi to create an action plan that includes training personnel to detect data integrity and manipulation issues. The API maker should also hire a third-party consultant, preferably someone with experience in detecting data integrity problems, the March 6 letter says.
Smruthi is the latest Indian drugmaker to draw a spotlight on quality issues.
Dr. Reddy’s Laboratories recently recalled 58,650 bottles of generic heartburn drug lansoprazole due to contamination issues, and Indian plants owned by Sun Pharma and Marck Bioscience were put on import alert due to good manufacturing practice violations.
The enforcement actions come as the FDA has decided to shift more GMP inspections overseas to reflect the growing number of drugs imported into the U.S.
Just because the FDA has recently decided to boost the number of inspections it conducts overseas doesn’t mean that you’ll soon be facing less scrutiny. Join in on FDA Compliance Boot Camp 2014: Validation, Data Security, Quality Risk Management and Compliance Training for the latest on how to get it done and done right.