"We do not consider your response acceptable because you failed to provide documentation for our review, which demonstrates that all your noted corrective actions have been effectively implemented. This documentation may include photographs, invoices, work orders, voluntary destruction records of any affected products, certification of actions performed by contractors, and/or any other useful information that would assist us in evaluating your corrections."
The initial inspection found a number of issues, nothing overly serious. but mostly what could be considered sloppy procedures. This included multiple condensation issues, improper sanitation procedures with instances where too high a sanitizer concentration was used, potential cross contamination issues, inadequate handwashing water temperatures, and improperly marked sanitizing agents. Environmental sampling of 100 samples was negative for Listeria monocytogenes, but one sample was positive for a non-pathogenic species of Listeria.
Clearly some bad vibes going on between the agency and the plant. If issues were so bad, why did a follow-up inspection not occur, or why wasn't this letter issued in March? A lot to take away from this.
- Tighten up procedures now rather than having an agency inspector tell you. Inspections are rarely perfect, but the number of issues seen here show a lack of attention to detail.
- Ensure corrective actions to inspection reports are completed as soon as possible.Those corrective actions must be detailed / documented to cover each and every element addressed in the inspection and be able to demonstrate that the risk issues have been adequately addressed . Overkill in documentation support was needed here rather than glossing over.
Boston Globe
https://www.bostonglobe.com/business/2016/06/14/whoole-foods-kitchen-everett-hit-with-food-safety-violations/U2oSoRitbt1FeV9s3hFf4K/story.html
FDA inspectors find evidence of Listeria at Whole Foods kitchen
By Megan Woolhouse Globe Staff June 14, 2016