Preparing for Inspection: WHAT TO DO WHEN THE FDA OR YOUR STATE'S REGULATORY AGENCY CALLS

摘要

When the Food and Drug Administration (FDA) comes to call, it's easyto assume that the agency has a right to see anything it wants. But in fact, the PDAs stamtory authority to conduct inspections has limits, and you have a right to limit the scope ofthe inspection under those stamtes. The same holds true for state regulatory agencies that conduct inspeaions of your feed manufacturing facility under the authority of state stamtes or regulations. While 70% of those inspetions are conducted under state rules, the FDA often asks state agencies to conduct inspeaions for the federal agency due to limited resources. Either way, you need to know their limits.