Screen Shot 2016-04-28 at 12.11.23 PMI always find FDA’s Form 483 Inspection Reports both interesting and educational.  It is too bad that the FDA tend to make getting copies of them difficult through requiring FOIA’s to be sent instead of simply making the investigation public.

Here are the high’s and low’s of the inspection at Dole’s Springfield Ohio facility which occurred after the plant was linked to a Listeria outbreak that began as early as July 5, 2015. On January 27, 2016, Dole issued a voluntary recall of all salad mixes produced at the Springfield plant. Thus far, 19 people in the United States and 14 in Canada have been identified as contracting Listeria from this outbreak, including one pregnant woman in Michigan. Every patient identified has been hospitalized, and 4 have died. 72% of US cases and 55% of Canadian cases are female. Every age group has been affected: in the United States, victims range in age from 3 to 83 years old.

On the first visits the FDA found:  OBSERVATION: “Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.”  The FDA through both product and environmental sampling found numerous samples positive for Listeria.  The FDA also noted that Dole was aware of positive Listeria tests from product that it had exported to Canada.  The FDA found that Dole in late January 2016 implemented a new “Environmental Program Corrective Action Report” apparently in response to a Listeria positive test by a third party laboratory.  FDA also noted that Dole had positive Listeria test dating back to at least July 2014.

Prior visits found:

OBSERVATION 1: “Failure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives.”

OBSERVATION 2: “The plant is not constructed in such a manner to allow floors and walls to be kept in good repair.”

OBSERVATION 3: “Failure to provide adequate screening or other protection against pests.”

Here is the 484 – Worth the Read.