Dear Editor,

Recently, a contributed opinion column on March 5, 2021, in Food Safety News made a case concerning food safety issues in the plant due to the FDA inspections or FSMA out of compliance issues. It listed a Top Ten list of typical challenges based on the experience of the writer as an FDA and legal expert of 42 years. The writer, Joseph Levitt, said he learned from food companies facing food safety and compliance challenges; one repeated phrase came through, “I wish I’d acted sooner.” He framed “acted sooner” as calling lawyers to advise how the manufacturer should defend themselves. The law is transparent concerning compliance. FDA findings from the Top Ten list relevant to reaching a lawyer after the incident has occurred. A lawyer, at that point, is after the damage is already done. “Sooner rather than later’”means following the legal requirements under the Food Safety Modernization Act (FSMA) to implement “preventive controls.”

In this discourse, we will show how (FSMA), if strategically implemented, will be aptly designated sooner rather than later. Operationalizing the law should be done electronically as a system, with error-proofing and management by exception for executing the controls — leaving the lawyering as a last resort. The need is to have an implemented system. 

Here is the Top Ten list and how each of the issues can be addressed in a thought out preventive electronic system with controls — to prevent the problems from occurring in the first place rather than after the fact — which then really requires a lawyer. 

  1. Notification of Outbreak: You have been contacted by the FDA and/or CDC that your company’s product has been associated with an outbreak of foodborne illness. You need help right away, to help you determine if the product needs to be recalled and if your plant needs to be shut down, and if so, what will be needed to restart.

117.139- Recall plan

You should have a written recall plan, which includes what will be needed to restart. However, according to the law, there is overlapping preventive control verification — the attendant, Internal PCQI, External PCQI. Three instances of review have to be bypassed to reach the customer to necessitate a recall. Strategic means — auto alerts to management when binary or monitoring values are not met or entered by the attendant at the point of application. Management immediately knows that there are occurring issues to address to nip the said issues in the bud. 

Restart will be triggered by an auto corrective action, which sends alerts when the corrective action is closed.

  1. Bad results from FDA swab-a-thon: You have been contacted by FDA and told that they took environmental swabs in your facility and found one or more positive findings of a food pathogen, such as Salmonella or Listeria. If not handled properly, this could be the beginning of bad things to come. That is because FDA will do DNA fingerprinting, called Whole Genome Sequencing (WGS), of your sample, keep it on file, and if they come back a year later and find the same thing, FDA could make you recall all product made in the intervening time under the “resident strain” theory.

117.135/117.150 Preventive Control / Corrective Action

The problem is not a positive environmental swab reading, but what is done about it. Therefore, you want a method to be immediately informed to be alerted, in the first place if the prescribed test is performed, triggers a non-conformance and a corrective action, and alerts that the corrective action was completed in the statutory time of seven days.  

  1. FDA sends you a warning letter: This means FDA has already determined that your product is legally adulterated or misbranded — you are officially on the naughty list — and if not remedied promptly, it could lead to any of the regulatory actions mentioned above. Note that FDA generally only sends one warning letter per facility, so just receiving it means you are in legal jeopardy.

117.135 Preventive Control 

It also means — your preventive controls are ineffective. It would help if you had preventive control with binary and/or monitoring features that trigger a non-conformance when either the requirements observed are not met or the monitoring value is out of range. The system cannot proceed until the triggered non-conformances are treated and verified by the internal PCQI (Preventive Controls Qualified Individual) and External PCQI electronically. 

  1. FDA invites you to a Regulatory Meeting:  This is an in-person version of the Warning Letter and carries all of the same cautions and risks.

117.301 Records

Records from the preventive control activity should be made available at the regulatory meeting, preferably electronically, which is time stamped with the people conducting the activities. Provide evidence of trained to employees to perform the activities at a specific points in the process. If the employee chooses not to treat with an auto corrective action, management is also electronically alerted. 

  1. You receive a second 483 Inspectional Observations report in the same facility: This is a red flag for the FDA. It means they feel they cannot trust you to fix your problems on your own. An escalation is almost certain to follow if you do not immediately change course and nip this in the bud. How you respond to that second 483 will be very important, and an experienced food regulatory lawyer can help you put your best foot forward.

117.150 Corrective Action.

An escalation can be avoided because immediately when an out of spec or binary requirement is not met all the elements of the corrective become available, and depending on what it is, validation 117.160 and reanalysis 117.170, if required, is included in the corrective action electronic format to enable improvements to change course. 

  1.  You receive your first 483 for a facility, but it is long, scary or the inspection itself was verbally contentious. FDA can escalate its activities even after a single bad inspection if the agency feels it went badly enough. At a minimum, you need a second opinion from an experienced food regulatory lawyer.

117.135 Preventive Controls

Before the 483, a rule of thumb is to identify a master list of all assets and surfaces and determine if a preventive control, including monitoring, covers it. A system is needed to determine if all assets/ surfaces compare to the master list and whether the preventive control per the prescribed frequency is completed for asset/surface and receive an alert when not completed.  A bad inspection triggers the corrective action. However, the preventive controls should minimize the occurrence of issues to cause a bad inspection. 

  1. Your finished product testing program shows a product positive for a food pathogen – usually Salmonella or Listeria. It is highly unusual to get even a single product positive, so this is an incredibly important warning signal. If an outbreak is a 5-alarm fire, a finished product positive is still a 3-alarm fire. You need to act quickly or the house could burn down. In addition to a food regulatory lawyer, you will also probably need an external scientific consultant to help you find the root cause and take necessary remedial action.

117.135/150 – Preventive Control /Corrective Action 

Once input into the system, your test results should trigger a corrective action for all product testing if product is positive.There should be an alert on the seventh day to complete and close the corrective action. If you are within the seven days, it cannot be registered as an FDA finding. Nevertheless, you need to have irrefutable records to demonstrate the timeframe because an FDA audit in the future, outside the statutory time frame — can result in a finding. Electronic real-time records will support the seven days. 

  1. You have a series of positive environmental findings in your facility for Salmonella or Listeria. This is an example of: Where there’s smoke, fire may follow. Remember that FDA will have access to those testing records, so these findings will become immediately visible to an FDA inspector. You need an objective viewpoint to assess whether or not your corrective actions will be seen by the FDA as sufficient. Always best to act before the FDA inspector is in your plant.

117.135/117.150 Preventive Control / Corrective Action 

The out-of-range test results should be immediately available to the attendant, triggered, and cannot be bypassed for that action, as corrective action is triggered, which must be acted upon within seven days. The fields in the corrective action should direct completing the corrective action. 

A subsequent alert is sent if it is late more than seven days and when the corrective action is closed.  

9. You have findings that make you question if you need to file with FDA a Reportable Food Registry (RFR) report. This is sometimes a tricky decision. If you decide not to file you should have clear written documentation as to your rationale and an objective second opinion that it is legally defensible.

117.301 Recordkeeping

FSMA never states that there cannot be a defect or non-conformance — it is the capability to manage and have the documentation to prove it. If your system captures your documentation as stated, your submittal of a file to the Reportable Food Registry will show the methodology to be correct. So with the correct method, the worst that could happen is the FDA can return it, with the confidence your methodology is intact. You are using the RTF to show off competence — less intrusion in the future. 

  1. You have findings that make you question if you need to recall a product, or if you should continue to ship a product. Often this will be related to the RFR decision-making above. You may have had an adverse incident at your plant, an unexpected spike in environmental test findings, or even a foreign material or quality issue. The same principle applies — make the right decision and document it well and get experienced advice in doing so.

117.139 Recall

Properly implemented – FSMA presents layered inspections or audits. 1) binary or monitoring parameters at the point of application that triggers non-conformance; 2) Internal PCQI verifies; 3) External receiving facility verifies. These three layers of verification should avoid recalls. If a recall is still needed, it can be done electronically.  

It is hoped that we could demonstrate the use of technology to operationalize FSMA with layered preventive controls, alerts to top management, and auto corrective actions to minimize the after-the-fact lawyering. The list of Top Ten issues can practically be eliminated ‘ sooner than later. 

— Jeffrey Lewis, Fellow Chartered Quality Institute, PCQI
Director of Safety In Your Hand Inc.

Editor’s note: This letter is in response to a contributed column by Joseph A. Levitt is a former director of FDA’s Center for Food Safety and Applied Nutrition. He is currently senior counsel in the Washington D.C. office of Hogan Lovells US LLP The law firm handles FDA and USDA food safety and compliance matters.

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