Date of Conferral
7-17-2026
Date of Award
July 2026
Degree
Doctor of Public Health (DrPH)
School
Health Sciences
Advisor
Twanda Wadlington
Abstract
Foodborne illness and food recalls remain major public health concerns in the United States. Guided by the Theory of Planned Behavior, the purpose of this quantitative secondary analysis was to examine whether Food and Drug Administration (FDA) inspection classifications, warning letters, and prior 24-month inspection frequency were associated with facility involvement in a subsequent Class I or Class II food recall. Question-specific analytic files were created from publicly available FDA administrative records. Eligible records included FDA-regulated food facilities with qualifying inspection or warning letter events and sufficient data to assess recall involvement within a 12-month follow-up period. The final analytic sample included N = 31,710 cases for Research Question 1, N = 25,763 for Research Question 2, and N = 7,970 for Research Question 3. Binary logistic regression showed that inspection classification was significantly associated with recall involvement, Wald χ²(2) = 232.05, p < .001. Relative to no action indicated, official action indicated was associated with higher odds of recall involvement, OR = 12.16, 95% CI [8.39, 17.60]. Voluntary action indicated was also associated with higher odds of recall involvement, OR = 3.40, 95% CI [2.75, 4.21]. Warning letter status was not a statistically significant predictor (OR = 1.29, 95% CI [0.69, 2.44], p = .428), and prior inspection frequency was not statistically significant (Wald χ²[3] = 0.29, p = .962). The findings suggest that inspection classification was the most meaningful regulatory signal examined. By clarifying the association between inspection classifications and recall involvement, the findings may help regulators prioritize prevention-oriented oversight for higher-risk FDA-regulated facilities.
Recommended Citation
Baker, Mark, "Food and Drug Administration Audit Outcomes and Their Association With Class I and Class II Food Recalls" (2026). Walden Dissertations and Doctoral Studies. 20410.
https://scholarworks.waldenu.edu/dissertations/20410
