Firm must have finished product or raw material in IS status.
REGULATORY ACTION GUIDANCE:
The following represents the criteria for the classification of an establishment as OAI.
1. If specific guides (i.e., smoked fish) exist in the foods sanitation area, call actionable if guide criteria met. Otherwise not actionable unless findings meet one or more criteria below.
2. Use of raw materials that are actionable as received under existing guide if EIR shows raw materials not cleaned or sorted before use to bring raw materials below guide figures.
3. Finished product examinations show it to be actionable under existing guides.
4. Live insects in establishment in such locations as to be a good possibility that raw materials, in process material, finished product, or stored food may have become contaminated by insects. (Probable avenues of contamination must be shown).
5. Fresh rodent or bird evidence in establishment in such locations as to be a good possibility that raw materials, in process materials, finished product or stored food may have become contaminated by rodent or birds. (Probable avenues of contamination must be shown).
6. EIR shows that food contact surfaces in use on day (or days) of inspection were not adequately cleaned before (or after) days operations and visible residues remain on such surfaces.
7. Glass breakage resulting in likely product contamination unless plant procedures are sufficient to insure removal of glass from food.
8. This guide obviously does not cover all actionable situations and if other situations occur that appear actionable the EIR should be forwarded to appropriate ORA Program Division Director with a specific recommendation for action.
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.