CPG Sec 555.500 All Food Sanitation (Including Bacteriological) Inspections - Classification of Establishment

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Issued by:: Guidance Issuing Office

Human Foods Program

Office of Inspections and Investigations

Manual of Compliance Policy Guides Chapter 5 - Food, Colors, and Cosmetics

POLICY:

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.

Issued: 10/1/80

Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

CPG Sec. 555.500 All Food Sanitation
(Including Bacteriological) Inspections -
Classification of Establishment
POLICY:
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.
Issued: 10/1/80

CPG Sec 555.500 All Food Sanitation (Including Bacteriological) Inspections - Classification of Establishment

Submit Comments

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