Lessons Learned from an FDA FSMA Inspection

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One of our clients recently experienced a full scope FDA FSMA inspection. The inspection was conducted by a state Ag Department under an FDA contract. The next few FSMA Friday articles will focus on some lessons learned and provide some tips to help you with your next inspection.

A Heads Up…This Time
The mill was contacted ahead of time and was told a date for when the inspection would start. Advance notice seems to be the norm during the COVID-19 pandemic. Keep in mind that advance notice is generally not given.

The client was also told the inspection would probably take place over the course at least part of three straight days which turned out to be the case. If you’ve been through inspections like this before you know that it will test your patience as you and your team answer questions and offer explanations as to how you do what you do. Day to day issues and challenges will continue to crop up and usually right around the time you are answering the same question for what feels like the fifteenth time. I am happy to say that the group at my client’s mill handled this very well.

Information Gathering
The client was asked to have information available at the start of the inspection including:
– Food Safety Plan (w/ hazard analysis)
– Current SOP’s
– Pest control and vegetation control documents
– Employee organizational chart
– A list of bulk and bagged macro and micro ingredients
– A map of property, to include labeled buildings, receiving pits and any other structures on the property.
– A flow chart or map of design structure or equipment of the mill from receiving to outgoing, a list of what is stored in the bins, size of bins, number of outbound bins.
– SOP training book with everyone’s acknowledgments.
– Documentation of PCQI training certificate.
The inspectors asked to review other documents during the inspection including customer complaints and the firm’s recall plan.

Questions for You
Does your firm have the documents on this list? Have you looked at these documents recently? Are they current or has something changed?
This may not be a complete list of items your inspector will request, but it likely covers most of what would be requested for review.

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Safety Regulations as Guardrails
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The Importance of Lockout/Tagout Procedures

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