us-fda-guidance-402ecd59f33afebe8d8db18b83d6e650•CPG Sec 550.685 Pineapple, Canned; Imported and Domestic - Misbranding Involving Food Standards
CPG Sec 550.685 Pineapple, Canned; Imported and Domestic - Misbranding Involving Food Standards
us-fda-guidance-402ecd59f33afebe8d8db18b83d6e650CPG Sec 550.685 Pineapple, Canned; Imported and Domestic - Misbranding Involving Food StandardsGuidance
Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.
Manual of Compliance Policy Guides Chapter 5 - Food, Colors, and Cosmetics
The following represents the criteria for direct reference seizure requests to the Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office within the Human and Animal Food Program.
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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. 550.685 Pineapple, Canned; Imported and Domestic - Misbranding Involving Food Standards REGULATORY ACTION GUIDANCE: The following represents the criteria for direct reference seizure *requests to the Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office within the Human and Animal Food Program*. Examination shows a number of cans deviating from standards that equals or exceeds the number under reject of the table with respect to one or more of the following individual factors: 1. *EXCESSIVELY TRIMMED - 145.180(b)(1)(iv) and (vii)* 2. *CORE MATERIAL - 145.180(b)(1)(i)* 3. *BLEMISHES - 145.180(b)(1)(iii)* 4. DRAINED WEIGHT FOR CRUSHED PINEAPPLE *145.180(b)(1)(vi)* 5. DRAINED WEIGHT FOR HEAVY PACK AND SOLID PACK CRUSHED PINEAPPLE *145.180(a)(6)(ii)* 6. IDENTITY OF CANNED PINEAPPLE *145.180(a)(1) and (2)*. If any lot or shipment of canned pineapple is in a form other than those described in *21 CFR 145.180(a)(1) and (2),* submit one can and records to U.S. Food and Drug Administration, CFSAN/Office of *Compliance/Division of Enforcement (HFS-605), 5100 Paint Branch Parkway, College Park, Maryland 20740,* for informational purposes. NOTE: The number of cans which deviate from the standards are those which have the same identity or quality factor, such as excessive trim, core material, blemishes, low drained weight, or improper identity, not a combination of identity and/or quality factors. For example, to detain or seize a lot based on the examination of 24 cans, 4 cans must be found substandard for trim or 4 cans substandard for blemishes, or 4 cans substandard for core, etc. Likewise, rejection of a lot based on examination of 48 cans requires 7 cans to be found substandard for trim, or 7 cans substandard for blemishes, or 7 cans substandard for core, etc. Use the criteria given in Compliance Policy Guide "Standardized Canned Fruit - Misbranding Involving Improper Declaration *of* Packing Medium" (See Sec 550.800 for CPG 7110.29).
CHECK ANALYSIS: If the original analysis shows a lot is subject to detention or seizure because of excessive trim, core material, or blemish, *contact the Office of Nutritional Products, Labeling, and Dietary Supplements, Compliance and Enforcement Team (HFS-820) to determine if a check analysis is required.*
*TABLE IMPORTED AND DOMESTIC CANNED PINEAPPLE ACTION CRITERIA* Sample Size No. Cans to be Examined Stage 1 Number of Defective Cans in Stage 1 Examination No. Cans to be Examined Stage 2 Number of Defective Cans in Total Sample Stage 1 plus Stage 2 Accept If Not More than Continue to Stage 2 if Reject If Equal to or More than Accept if Not More than Reject if Equal to or More than 24 12 1 2,3 4 12 3 4 36 18 1 2,3 4 18 5 6 48 24 2 3,4 5 24 6 7 *Material between asterisks is new or revised* Issued: 10/1/80 Revised: 3/95, 5/2005 Updated: 11/29/05
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