"Our inspection of QC Analytical and Microbiological laboratories found the facility to be in significant disrepair. Laboratories windows within the instrumentation (eg: HPCL) rooms were found to be un-closeable. "Too Numerous To Count (TNTC) flies were observed throughout the sample preparation room, and laboratory re-agent/equipment/documentation storage cabinets were found to be broken and un-closeable," FDA inspection report said.
Earlier this week, FDA banned the import of Ranbaxy products from its Toansa plant, halting the shipment of all the company's drugs to the US from India. This is the company's fourth plant to face regulatory action from the American health regulator after Mohali, Paonta Sahib amd Dewas plants. Citing manufacturing norm violations, the US Food and Drug Administration (USFDA) prohibited Ranbaxy Laboratories from distributing drugs produced at the Toansa unit, including medicines made by the company's Ohm Laboratories facility in New Jersey. Expressing disappointment over the FDA ban, Ranbaxy had said it will cooperate with the FDA and "comply with Consent Decree in both letter and spirit". The FDA inspection report further said that the Indian drug maker repeated the same errors which were cited by the regulator in its earlier inspection in December 2012. "Appropriate controls are not established over computerized systems... This is a repeat observation from the previous FDA inspection in 12/2012.
"Specifically the standalone computerized system controlling GC# 6 does not have sufficient controls to prevent unauthorized access to, changes to, or omission of data files and folders," the report said.
The audit team said that the raw material, intermediates and finished API (active pharma ingredients) analytical results found to be failing specifications or otherwise retested until acceptable results are obtained. These results are not reported. (PTI)