FDA Inspections/Investigations
Good day Everyone,
I know this question is being ask already but I have been out of the site for a while.
Could anybody share the latest experiences with FDA Inspections/Investigations? Just curious to see what are the main objectives.
I work in a Spice and Extract Operation and we had FDA/ State of Texas Observation visit but we were alerted of the "SWABATON" coming.
Any experiences you can share will greatly appreciated.
Glad to be back
K
I had them in Tuesday and Wednesday actually. No swabbing - they just wanted to observe processing/sanitation, look over FSPs, allergen management, training, and supplier approval documentation.
They have never swabbed our facility before.
I was at a company still new and right before I got there they informed me they did get a FDA visit for swabbing. They told me they took around 20 samples from different areas in the facility (different zones) and swabbed for Salmonella & Listeria. They simply want to test your EMP.
This may help you:
We have a site that the FDA is currently at. They are wrapping up day 2 and are planning on returning tomorrow. No swabbing, but did reference their website for us to get an idea of what to expect. It can be found here: https://www.fda.gov/...mental-sampling .
We are seeing them dig through about 1.5 years of records - reviewing every entry, etc. They informed us that 'this is nothing' and we can expect a full week next time. Much different then their visit 2 years ago, which was only 1.5 days and was more risk based on how they approached documents and records.
Much tougher this time around.