Flies found in Toansa plant of Ranbaxy's storage room: FDA

Earlier this week, the US regulator banned the import of Ranbaxy products from its Toansa plant, halting the shipment of the company's drugs

Presence of flies in sample storage room, un-calibrated instruments in laboratory and non-adherence to sample analysis procedure were among the lapses found in Ranbaxy's Toansa plant that led to US Food and Drug Administration (FDA) banning imports of drugs made at the facility.

According to the report released by the FDA inspection teams, eight lapses were identified, including "too numerous to count (TNTC) flies" in sample storage room, inadequate control over samples and non-adherence of procedures in sample analysis, during their visit to the Toansa facility in Punjab. Other lapses included usage of un-calibrated and unqualified instruments in the laboratory, said the report released two days ago.

"Our inspection of QC Analytical and Microbiological laboratories found the facility to be in significant disrepair. Laboratories windows within the instrumentation rooms were found to be un-closeable. 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 US health regulator after Mohali, Paonta Sahib and Dewas plants. Citing manufacturing norm violations, FDA 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 said it would cooperate with FDA and "comply with Consent Decree in both letter and spirit".

The FDA inspection report further said 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 computerised systems... Specifically the standalone computerised system controlling GC# 6 does not have sufficient controls to prevent unauthorised 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 active pharma ingredients analytical results found to be failing specifications or otherwise are retested until acceptable results are obtained. These results are not reported.

The FDA notice said Ranbaxy is required to hire a third- party expert to thoroughly inspect the Toansa facility and certify to the FDA that the facility and its methods and controls are adequate to ensure continuous compliance with Current Good Manufacturing Practices.

"Ranbaxy will not be permitted to resume manufacturing and distributing API for FDA-regulated drugs from the Toansa facility until the agency is satisfied that Ranbaxy has addressed its manufacturing quality issues at that facility," it further said.
TROUBLED TIMES
Lapses found:

• "Too numerous to count" flies found in sample storage room, un-calibrated instruments in laboratory
• Usage of un-calibrated and unqualified instruments in the laboratory
• Laboratories windows within the instrumentation rooms found to be un-closeable
• Ranbaxy repeated the same errors which were cited by FDA in its earlier inspection in December 2012