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FDA 2009:Guide 3-B Instructions for Marking the Food Establishment Inspection Report, Including Food Code References for Risk Factors/Interventions and Good Retail Practices

11. Food in good condition, safe and unadulterated

IN/OUT    This item must be marked IN or OUT of compliance based on direct observations of the integrity of product packaging, wholesomeness, and signs of adulteration. This item must be marked IN compliance when a dent in a canned food has not compromised the hermetic seal; cuts made in outer cardboard packaging during opening of the case do not enter the inner product packaging; the true appearance, color, or quality of a food is not misrepresented; and food is honestly presented. This item must be marked OUT of compliance when the integrity of food packaging has been compromised or the true appearance, color, or quality of a food has been intentionally altered.

Applicable Code Sections:
3-101.11 Safe, Unadulterated and Honestly Presented
3-202.15 Package Integrity

101.11 Safe, Unadulterated, and Honestly Presented.
Food shall be safe, unadulterated, and, as specified under § 3-601.12, honestly presented.

202.15 Package Integrity.
Food packages shall be in good condition and protect the integrity of the contents so that the food is not exposed to adulteration or potential contaminants.

FDA Food Code 2009: Annex 3 - Public Health Reasons / Administrative Guidelines - Chapter 3, Food

3-202.15 Package Integrity.

Damaged or incorrectly applied packaging may allow the entry of bacteria or other contaminants into the contained food. If the integrity of the packaging has been compromised, contaminants such as Clostridium botulinum may find their way into the food. In anaerobic conditions (lack of oxygen), botulism toxin may be formed.

Packaging defects may not be readily apparent. This is particularly the case with low acid canned foods. Close inspection of cans for imperfections or damage may reveal punctures or seam defects. In many cases, suspect packaging may have to be inspected by trained persons using magnifying equipment. Irreversible and even reversible swelling of cans (hard swells and flippers) may indicate can damage or imperfections (lack of an airtight, i.e., hermetic seal). Swollen cans may also indicate that not enough heat was applied during processing (underprocessing). Suspect cans must be returned and not offered for sale.


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