Flies in sample storage room: What FDA report on Ranbaxy's Toansa plant said

Hyderabad: Presence of flies in samplestorage room, un-calibrated instruments in laboratory andnon-adherence to sample analysis procedure were among thelapses found in Ranbaxy’s Toansa plant that led to US healthregulator FDA banning imports of drugs made at the facility.

According to the report released by the US Food and DrugAdministration (FDA) inspection teams, as many as eight lapseswere identified, including “Too Numerous To Count (TNTC)flies” in sample storage room, inadequate control over samplesand non-adherence of procedures in sample analysis, duringtheir visit to the Toansa, Punjab facility.

Other lapses included usage of un-calibrated andunqualified instruments in laboratory, said the report, whichwas released two days ago.

[caption id=“attachment_1360419” align=“alignleft” width=“380”]  Representational image. Reuters[/caption]

“Our inspection of QC Analytical and Microbiologicallaboratories found the facility to be in significantdisrepair. Laboratories windows within the instrumentation(eg: HPCL) rooms were found to be un-closeable.

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“Too Numerous To Count (TNTC) flies were observedthroughout the sample preparation room, and laboratoryre-agent/equipment/documentation storage cabinets were foundto be broken and un-closeable,” FDA inspection report said.

Earlier this week, FDA banned the import of Ranbaxyproducts from its Toansa plant, halting the shipment of allthe company’s drugs to the US from India.

This is the company’s fourth plant to face regulatoryaction from the American health regulator after Mohali, PaontaSahib and 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.

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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 computerised systems… This is a repeat observation from the previous FDA inspection in 12/2012.”

“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 API (active pharma ingredients) analytical results found to be failing specifications or otherwise 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 cGMP (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.

PTI