Friday, April 29, 2016

FDA Inspection Report from Salad Facility Responsible for Listieria Outbreak

Earlier this year, bagged salads produced by Dole in their Ohio facility, were involved in a Listeria outbreak.  According to the CDC Final Report, issued March 31 2016, 19 people became infected and there was 1 death.  In Canada, the CFIA reported 14 cases  and 3 deaths, although stated that the deaths may or may not be related to Listeria monocytogenes (LM).

FDA conducted an investigation of the facility and during that investigation, completed environmental sampling.   A 483 report was issued, and thanks to the Marler Blog, that report was posted (a 2014 report was also included there, but was not included here).  In reviewing this 483 report, there were some important findings.   A summary of those below as well as reports.
(An FDA 483 Report 'lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance')

Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.

Here is a interpretation of those findings.
a. FDA found positive LM samples on contact and non contact surfaces as well as finished product.  FDA also makes note that the Canadian Food Inspection agency found positive product samples.  The isolates match those samples recovered from patients.
b. The facility only takes pre-operational, non-contact surface samples and does not sample product contact surfaces nor does it take samples during operation.
c. The facility only recently started doing a corrective action for suspect samples (Listeria species) found in the environment.

So Observation 1 is basically stating because FDA found LM in the facility and on product, the facility was not doing enough to control LM as evidenced by a weak sample program.

Just to point out from the 2014 FDA inspection report - although a lot of facility related items are mentioned, there is no mention of Listeria or Listeria sampling.


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