Application Note

How To Avoid (And Respond To) FDA 483s For Temperature, Humidity And Other Controlled Environments


No cGMP compliant manufacturer wants to receive a Form 483 (“Notice of Inspectional Observations”). In such stringently controlled industries as pharmaceutical/ biotechnical development, manufacturing and warehousing, receiving a list of deficiencies can feel like a heavy blow to your quality system. Worse, with the 2009 increase in enforcement staff 1 and the September 2009 change to the response time – now 15 days – the FDA appears to be ramping up its enforcement mandate.