Following the issuance of a 483 to a baking company, to which it did not respond, FDA issued a warning letter focused on the company’s incomplete hazard analysis, GMP concerns, and lack of allergen controls:
- Hazard Analysis: Environmental pathogens were not considered as a potential hazard even though food products were exposed to the environment after a lethality step; mycotoxins were not identified as a potential hazard in flour; sesame was not included as part of the identified allergens and not identified as a potential hazard.
- Allergens: In addition to not being identified in the hazard analysis, sesame seeds were observed on trays used for buns that did not contain sesame seeds.
- GMPs: Observations included food residues on product contact surfaces; dust and flaking paint on overhead surfaces; live pests and pest activity; lack of hair restraints.
While it can be easy for a facility to overlook day-to-day controls, all are critical to food safety and their lack will be cited by the FDA. It can be helpful to employ the assistance of a third party who can provide an extra set of eyes and expert assessment and assistance.
