FDA Issues Summary of Inspection Items Listed on 483 Reports Issued in FY2017

FDA posted the summary of inspectional observation items listed on 483 reports from FY 2017 (10/2016 to 9/2017). During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements. "These spreadsheets are not a comprehensive listing of all inspectional observations but represent the area of regulation and the number of times it was cited as an observation on an FDA Form 483 during inspections conducted by FDA and its representatives."

According to the posting, there were 2662 483's issued during FY 2017, compared to 2196 in 2016.    While the top 5 are similar to those listed in 2016, and most issues involve pest control, sanitation, processing concerns, and building  structure issues, there is a new item which is the Failure to Develop a FSVP (Foreign Supplier Verification Program).  The FSVP is for controlling foreign suppliers when a company not operating under Preventive Controls is importing the food.

Warning Letter Issued to WA State Frozen Food Processor Responsible for Listeria Related Recall

FDA issued a warning letter in response to Oregon Food Company correction of inspection items as part of the Listeria recall of frozen produce.  A few things to note 1) the number of the issues the facility had in the inspection and the fact that they had a pretty big Listeria issue, and 2) their responses were rejected because while the facility addressed items they had to fix, they did not show that the fixes actually worked and that they implemented procedures for ongoing verification.  This is a good lesson in the issues that the plant faced, but also in how to, or how not to, respond to a FDA 483 report.
 
First, the letter points out that FDA found 19 Listeria positive environmental samples with 7 of those being food contact surfaces including a chiller water system (that did not have sanitizer).  These samples were linked via Whole Genome Sequencing to clinical isolates.  While the firm corrected the facility issues, FDA stated that this was not enough. "While we acknowledge these are appropriate actions to be taken, we are unable to fully evaluate the adequacy of these actions at this time without further details, documentation and results of your corrective actions."  So basically, they want to see results from extensive sampling, including when the plant is operating, that the organism is not present.

 

On GMP issues, the facility was found to be not as clean as it should have been.  While the plant indicated it trained the employees, FDA found the response lacking.  ."your response did not provide any details as to the content of this training or how you will ensure this training is effective by assessing and monitoring employee performance and adherence to the training."

 
The facility had many condensation issues, which is not good from controlling Listeria.  While the facility responded that they fixed sources of condensation, FDA responded "how you will assess whether this correction and the [fixes] are effective in minimizing the condensation above food and food contact surfaces. Your response does not address how to you will prevent future recurrence of this violation, such as through increased monitoring and assessment."

 

The facility had poorly made food contact surfaces that would provide harborage.  While the facility had repaired the surfaces, FDA responded "you provided no documentation or details on how you will ensure the repairs are adequate. Your response does not address how you will prevent future recurrence of this violation. "

 

In addition, there were steam ventilation issues and general facility issues.  Again, fixes were made, but the outcome of those fixes and measures to prevent reoccurrence were not addressed.

 

 

FDA Warning Letter

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm512776.htm

Oregon Potato Company 7/15/16

 

FDA's Inspection Report for Apple Facility Involved in Caramel Apple Listeria Outbreak

FDA had issued a 483 Report on the Bidart Apple operation in light of the Caramel Apple Listeria outbreak.   This 483 Report made available through the Marler Blog  indicated the following:

• Of the 110 environmental samples taken, 7 were confirmed positive for Listeria monocytogenes with 6 of these being direct food contact surfaces.  These included the polishing brushes and the wooden bins.
• FDA observed food contact surfaces on packing equipment that were not maintained in a way that could be easily cleaned and sanitized.
• Exposed foam padding material on a packaging line (again, something that is not only difficult to clean, but can be a collection point for contamination).
• A bucket conveyor system made of a canvas material that had frayed ends (another material not easily cleaned).
• Torn / cracked flaps for controlling apple flow.

In summary, this is a facility that had a number of design /maintenance issues that made cleaning the microbiological level difficult.  Listeria was found on the line  immediately before final packing (the brushes) but were also found in a bin.  These items indicate the contamination was present, but offer little information on the initial source of contamination and conditions that lead proliferation on/in the apple.