Application Note

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

Source: Vaisala, Inc.
TipsForRespondg

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.

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