Pan Drugs Production Manager Fabricated Signatures, FDA Says in Warning Letter
Pan Drugs, located in India, has received a warning letter due to a series of cGMP violations found during an inspection last year.
The inspection revealed a failure to establish an adequate quality control unit, and the production manager at the facility admitted that he falsified the signatures of other employees in the “Prepared By,” “Reviewed By,” “Approved By,” and “Authorized By” sections of various production records.
Additionally, Pan’s quality control unit failed to identify data integrity issues in 11 batch production records reviewed by FDA investigators and did not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured at the plant. The agency recommends a comprehensive investigation into the extent of inaccuracies in data records and reporting.
FDA investigators also discovered Pan failed to maintain the buildings used in the manufacture, processing, packing, or holding of drug products. Investigators found mold–like substances on the walls of the processing area, gaps and holes in walls, insects and pests exiting through the holes, rodent droppings and an accumulation of powder throughout the facility.
Investigators also observed a warehouse supervisor tearing out pages from the firm’s annual report and placing the pages into his pocket. Eventually, the supervisor provided the pages to investigators.
Other sanitation violations include rust, dirt, and lubrication leaks on and around shared drug manufacturing equipment and no cleaning procedure for the equipment or facility.
Over the last few years, U.S. and U.K. regulators have increased their focus on data integrity with drugmakers. Take advantage of this opportunity to learn from the successes — and mistakes — of other drug companies similar to yours. Avoiding Data Integrity Breaches: A Guide for Drugmakers show you how to find and fix data integrity problems with a tried-and-tested, proven approach.
