Since the beginning of 2023, FDA has issued nearly 40 warning letters with citations for lack of or inadequate HACCP implementation. This doesn’t even begin to account for the number of 483 citations on Juice or Seafood HACCP during that time, as warning letters are issued when a company does not respond, or provides an inadequate response, to a 483.
It also is important to note that warning letters are posted openly on FDA’s website “naming names” and causes for the warnings, while 483s, which are issued at the close of an inspection, are not made public. So it is much better to review the observations in a 483, determine the root causes, take corrective action, and respond to FDA with documentation to avoid the potential of a warning letter, public disclosure, and other possible FDA action.
There is a caveat here. While the 483s are not made public, FDA does compile an annual list of Inspection Observations (without naming names), including a description of each citation and the regulatory provision that was violated. An analysis of these can provide facilities with a sort of checklist by which to conduct your own internal inspection and determine any areas in which you could be cited as well – such as the numerous seafood and juice HACCP citations issued in FY23. While these do not, of course, cover everything a facility needs to consider in its HACCP program, it does provide for some of the top trouble areas in complying with 21 CFR 123 related to Seafood HACCP and 21 CFR 120 related to Juice HACCP.
For both seafood and juice facilities, one of the most basic 483 observations was that the facility had no HACCP plan at all, or there was a plan, but it was not fully implemented, as required by law. For those that did have HACCP, it was its first principle, the hazard analysis, that was most often cited as lacking – from not having a hazard analysis at all to not considering all potential hazards. As indicated by the “HA” in HACCP, the hazard analysis is a basic component and the foundation upon which all else stands. As defined by FDA, the hazard analysis is “the process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.” From that, the purpose is to determine those hazards that are of such significance that they are reasonably likely to cause injury or illness if not effectively controlled. These then become the basis of the HACCP plan, while those that are not reasonably likely to occur would not require further consideration within a HACCP plan. (FDA)
Also frequently cited was inadequate listing of all needed critical control points (CCPs), which is not only the second principle of HACCP, but also plays back into the adequate listing of hazards (if you haven’t considered all significant hazards, you can’t know where a critical control point may be needed.) Again, the importance of CCPs are reflected in the HACCP name, reflecting a step at which a control is essential to prevent, eliminate, or reduce to an acceptable level a food safety hazard. Thus, the lack of a needed CCP, or an inadequately developed critical limit (the third principle) for an identified food hazard at a CCP can result in a citation.
Beyond these three basic components of the HACCP, frequent citations were made for inadequacy or lack of:
- Monitoring (fourth principle). Having adequate, planned procedures and timeframes for assessing the effectiveness of the CCPs is critical to determine when a deviation occurs that requires a corrective action, or to identify a trend toward a deviation that may need attention. Not having adequate procedures, implemented monitoring, or documentation can all result in citations.
- Corrective Action (fifth principle). Not implementing corrective action for an affected product, having a corrective action plan that does adequately address the hazard, or not documenting that a corrective action was taken (even if it was actually implemented). Without the implementation of a corrective action, a defective product can go to market, potentially causing significant injury or illness.
- Verification (sixth principle). With verification being activities that determine the validity of the HACCP plan and its operation according to plan, it is another of the seven principles of HACCP. Thus, it is an essential part of the plan to ensure that it is adequate to control food safety hazards, and that it is being effectively implemented.
- Recordkeeping (seventh principle). The old saying “if it’s not written, it didn’t happen” could have been written about HACCP, as a lack of documentation of any one of the seven principles can be cause for a citation. Even the lack of a signature and date or the inability to produce records for officials can be cause for a 483.
Prior to FSMA, HACCP was one of the primary ways that the food industry developed food safety plans. With the passage of FSMA, the regulatory requirements went beyond HACCP to “HARPC” which still requires a Hazard Analysis (HA) but adds requirements for Risk-based Preventive Controls (RPC). Unlike FSMA’s HARPC, however, HACCP had not been required of FDA-regulated facilities – except for seafood and juice. Thus, in guidance, FDA recognized the previously established preventive control type regulations for fish and fishery products and juice products (i.e., HACCP) and maintained this as the primary set of rules for these segments, exempting them from many provisions of FSMA.
Given that these industries are subject to some provisions of FSMA, but also regulated by HACCP – which can be complex in and of itself, it’s not a surprise that inspections may be followed by 483s. Given the additional complexity of working through the violations, assessing root causes, implementing corrective action, then documenting all that in a written response to FDA to avoid a warning letter or other potential action.
But – it is an area where TAG can be of great help! TAG’s food safety consulting experts in HACCP, FSMA, seafood and juice can assess your plans and implementation to help ensure you pass the initial inspection; help you work through root cause, corrective actions and response to a 483; or even assist in responding to a warning letter to avoid further enforcement action from FDA.
Whether you need prevention or reaction, TAG can help. Give us a call today!
