What FDA Has to Say About: Top 483 Observations, a New Reporting Option, Allergen Threshold Levels

A review of the top inspectional observations, a new way of reporting a facility’s related corrective actions, and the suggestion that the agency may be open to entertaining threshold levels for allergens were three of the areas discussed in FDA Updates at the October Food Safety Preventive Controls Alliance conference.

Of the noncompliance observations made by FDA during food facility inspections (FY19-23) as cited on a Form 483, 90% were related to GMPs. Specifically, the Top Ten 483 observations were related to:

1. Pest control (21 CFR 117.35(c))
2. Sanitary operations and maintenance (21 CFR 117.35(a))
3. The identification of hazards in the hazard analysis (21 CFR 117.130(a)(1))
4. Equipment & utensil design & maintenance (21 CFR 117.40)
5. Manufacturing, processing, packing & holding controls (21 CFR 117.80 (c))
6. Personnel (21 CFR 117.10)
7. Plant construction & design (21 CFR 117.20(b))
8. Frequency of sanitation of food-contact surfaces (21 CFR 117.150(d))
9. Sanitation operations related to plant sanitation (21 CFR 117.35(a))
10. Sanitary facilities & controls (21 CFR 117.37)

While not listed as one of the top ten, an update also focused more specifically on the number of FSVP noncompliances, with the top reason for the issuance of a 483 being the “lack of an FSVP.” Accounting for 35% of the citations, this shows that FDA is looking at and expecting FSVP documentation – and citing companies that don’t have it.

When inspectional observations are made, it is the facility’s responsibility to take corrective action. To enhance the process of submitting documentation of corrective action taken to address these, FDA has rolled out a new online reporting program, OCAR (Observation and Corrective Action Reports). Eligible firms that meet selection criteria will be offered the opportunity to participate in Phase 1 of the Industry Portal.

The voluntary system enables food facilities to electronically submit documentation of the corrective action they have in process through an online portal. Through the portal, the firm can track the progression of their corrective action response through FDA’s system to allow them to see its status. The system can also be used for “discussion items” raised during an inspection (to help keep it from being escalated to a 483), as well as 483 responses.  

Currently, the portal is available to domestic human/animal food facilities that have had an inspection conducted with observations documented (FDA Form-483 items and/or discussion items). If a facility qualifies, they will be offered the opportunity to participate in the portal during the closing meeting of the inspection. If interested, the firm must notify FDA at that time or within five days of the close of the inspection.

The FDA Update also contained an interesting nugget of potential opportunity for industry. As we discussed in an October article, FDA released two more chapters on draft guidance for the PC Rule, one of which related to food allergens. In discussing that guidance, the FDA called out a notable key update in that guidance: “FDA has not established a maximum amount of food allergen that may be present in labeled food products without need for declaration. However, FDA recognizes that published data on population threshold dose responses to various food allergens are becoming increasingly available” that raise the possibility that some low-level exposures and allergen-derived ingredients may not always cause allergic reaction in most of those with that food allergy.

This is followed by a statement in the guidance that: “Food manufacturers/processors could evaluate such data in light of their specific products, such as through risk assessments or other scientifically valid assessments, in making decisions on appropriate food allergen controls.” This suggests that the agency may be open to entertaining threshold levels for allergens as part of a risk assessment process – a significant change from their previous stance. It is critical to note, however, that any such considerations would need very strong justification from the PCQI.

We would expect that there will be many comments supporting this. But we also would expect industry to be very cautious about implementing it, at least in part due to the stipulation that the low levels or allergen derivations may not cause allergic reactions “in most consumers who have that food allergy.” In such situations, companies often prefer to exhibit an abundance of caution.

TAG will continue to provide additional nuggets from and expert commentary on the FSPCA conference in future newsletters. If you aren’t subscribed, click here to stay up to date on industry news and events.