Too many flies in sample storage room led to US ban on Ranbaxy
Presence of flies in sample storage room and non-adherence to sample-analysis procedure were among the lapses found in Ranbaxy's plant in Punjab that led to US health regulator FDA banning imports of drugs made at the facility.chandigarh Updated: Jan 26, 2014 17:12 IST
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 in Punjab's Nawanshahr district that led to US health regulator FDA banning imports of drugs made at the facility.
The report released by inspection teams of the US Food and Drug Administration (USFDA) said eight lapses were identified during their visit to the facility.
The report, which was released two days ago, said there was inadequate control over samples. "Our inspection of laboratories found the facility to be in significant disrepair. Laboratories windows within the instrumentation (eg: HPCL) rooms were found to be un-closeable," it said. "Too numerous to count flies were observed throughout the sample preparation room, and laboratory re-agent/equipment/documentation storage cabinets were found to be broken and un-closeable," USFDA inspection report said.
Earlier this week, USFDA banned the import of Ranbaxy products from its plant in Nawanshahr, 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 and Dewas plants.
Citing manufacturing norm violations, the USFDA prohibited Ranbaxy Laboratories from distributing drugs produced at the Nawanshahr unit, including medicines made by the company's Ohm Laboratories facility in New Jersey. Expressing disappointment over the FDA ban, Ranbaxy had said it would cooperate with the FDA and "comply with Consent Decree in both letter and spirit".
The FDA inspection report further said that the Indian drugmaker 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," it said. "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."