Hiding Cancer Drug Manufacturing Records Costs Fresenius Kabi $50M In US Settlement
It turns out there’s a price to pay for removing computers and chromatography instruments so their data can’t be inspected.
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Data integrity failures are so yesterday. Now it’s all about poor investigations into out-of-specification results.
New Year’s resolutions anyone? Generic drug maker Fresenius Kabi closed out the year with the unlucky distinction of receiving not one – but two – drug GMP warning letters from FDA last month. The agency chastised the firm for not reporting failing test results and not getting to the root cause of sterility failures. The firm was also criticized for not learning from earlier mistakes.
How FDA Will Use Its New Authority against Denying, Limiting or Refusing Inspections – And Why Industry is Still Worried
How will FDA use its recently drafted guidance against obstructing inspections? Industry fears it may depend on how individual investigators interpret terms like “reasonable.”