FDA notes flies in sample storage room at Toansa plant
Not limiting the issues at Toansa plant to only data integrity, USFDA also finds some more lapses and good manufacturing practice (GMP) standards during its inspection. It has noted the presence of flies in the plant’s sample storage room, laboratory instruments that were un-calibrated and there was also non-adherence to sample analysis procedure. All these along with the data integrity violations have resulted into an import ban of drugs manufactured at the Toansa plant. As stated by the USFDAs report, around eight lapses were mentioned and the findings of flies said they were too numerous to count flies. Another finding said that the laboratory windows were un-closeable and the storage cabinets were broken or not in a position to be closed.
Owing to GMP standard violations, the USFDA has prohibited Ranbaxy Laboratories from marketing drugs manufactured at the Toansa unit and also included products manufactured by the companys Ohm Laboratories facility in New Jersey. FDA states that there has been repeated observation and appropriate controls are not established over computerized systems.
The company states that it is willing to co-operate and would take the necessary actions to resolve this issue at the earliest.