REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure to Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices.
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:
- *EXCESSIVELY TRIMMED - 145.180(b)(1)(iv) and (vii)*
- *CORE MATERIAL - 145.180(b)(1)(i)*
- *BLEMISHES - 145.180(b)(1)(iii)*
- DRAINED WEIGHT FOR CRUSHED PINEAPPLE *145.180(b)(1)(vi)*
- DRAINED WEIGHT FOR HEAVY PACK AND SOLID PACK CRUSHED PINEAPPLE *145.180(a)(6)(ii)*
- 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|
*Material between asterisks is new or revised*
Issued: 10/1/80 Revised: 3/95, 5/2005