FDA Cites Lupin For Poor Quality Metric Performance
Indian firm's invalidated out-of-specification rate was too high, FDA suggests in heavily redacted Form 483 report. This rate, which also came up in two recent warning letters, happens to be one of the three rates the USagency wants to use as quality metrics for deciding how soon investigators should revisit sites.
You may also be interested in...
Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.
Apotex warning letter reflects FDA’s emphasis on company-wide quality systems and invalidated OOS results.
Mylan can look forward to mopping up some major cleaning validation issues a large team from FDA found during an extensive inspection of the firm’s West Virginia plant. Meanwhile, an API firm in China found it should not have left blank product release forms lying around pre-stamped “Permitted to Leave Factory.”