REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct citation by ORA Field Offices:
- Infestation: Inspection shows substantial insect, rodent, or bird infestation of an establishment manufacturing or storing food for human use, with direct avenues of contamination, with or without filth findings in correlated samples.
- 1080 Rodenticide: Inspection shows careless use of 1080 in an establishment manufacturing or storing food for human or animal use.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.