- The U.S. Food and Drug Administration hit another Indian drugmaker with a warning letter detailing serious data manipulation and quality control violations, continuing its recent amped-up scrutiny of manufacturing facilities in that country.
- Sri Krishna Pharma lacked basic controls on its production and control records, allowing junior staff to access testing instruments using "Admin" log-ins. Inspections found the company was destroying original records and replacing them with backdated pages.
- The letter strongly criticizes the firm for failing to ensure quality and safety of the drug products it manufactures, particularly after an inspection in 2007 had identified similar issues.
The Hyderabad-based firm is only the latest manufacturing facility to be hit with a warning letter from the FDA. A review of documents posted on the FDA's website reveals the agency has sent more than a dozen manufacturing-related warnings to India-based facilities. The FDA currently bans imports from 42 Indian firms.
Many of those letters reveal similar deficiencies. Facilities frequently lacked sufficient controls on computer systems, allowing the improper alteration or deletion of electronic records. While Sri Krishna is a smaller firm, big name India pharma companies like Sun and Dr. Reddy's have also been flagged for violations.
Inspections at Sri Krishna's facility revealed lab records did not contain complete raw data from testing of finished drug products. Analysts either failed to report all results or deleted original data, and some batch records included backdated pages to replace destroyed originals.
An FDA investigator also found original pages from five different batch records thrown away outside the facility.
Despite attempts to initiate a qualification protocol for manufacturing equipment, Sri Krishna didn't implement it and shipped batches of product to the U.S. which had been manufactured using the invalidated process.
"The examples above are serious CGMP violations demonstrating that your quality system does not adequately ensure the accuracy and integrity of the data generated at your facility to support the safety, effectiveness, and quality of the drug products you manufacture," the letter said.
The FDA demanded Sri Krishna conduct a comprehensive investigation and put in place a corrective action plan. If the drugmaker fails to do so, the FDA can deny the import of products made at the Hyderabad plant.