Source: http://www.accessdata.fda.gov/cms_ia/importalert_1132.html
Timestamp: 2015-03-05 02:42:32
Document Index: 470957197

Matched Legal Cases: ['art 108', 'arts 113', 'art 108', 'art 113', 'art 108', 'art 113']

Import Alert 99-38
Import Alert # 99-38
FDA conducts inspections to ensure commercial processors of low-acid canned food (LACF) and acidified food (AF) products adhere to, among other things, the mandatory requirements of 21 CFR Part 108 and the LACF and AF Current Good Manufacturing Practices (CGMP) regulations under 21 CFR Parts 113 and 114. FDA also conducts field exams and sample analyses of LACF and AF products offered for entry. When establishment inspections, analytical results, field exams, or other data and information demonstrate that the products were not properly manufactured to control growth and toxin production from Clostridium botulinum or other microorganisms of significance to public health, FDA may subject the commercial processor and the affected products to this alert. This alert will be used only in circumstances where a determination has already been made by the firm that a product is LACF or AF based on their submission of scheduled processes to FDA.This alert was created to cover Detention Without Physical Exam (DWPE) of products due to inadequate process control previously covered under 99-04.
Districts may detain, without physical examination, the specific product(s) listed for the firms identified in the Red List of this import alert. For questions regarding whether products are covered, contact CFSAN/OC/DE/FAAB. For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at 301-796-5992. In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. To request removal from detention without physical examination, the firm, shipper, or importer should submit a request to FDA at the following address: Food and Drug Administration Center for Food Safety and Applied Nutrition Food Adulteration Assessment Branch (HFS-607) 5100 Paint Branch Parkway College Park, MD 20740 The request should provide sufficient information to demonstrate compliance with the applicable provisions of 21 CFR Part 108 and Part 113 or 114. Examples of information that processors may provide to demonstrate compliance with the requirements include: � Records to demonstrate that the products were manufactured according to the firm�s scheduled process. � Photographs showing the manufacturing equipment. � Documentation showing that the process has been evaluated by a recognized process authority. � Heat penetration data. � Certification from a third party that the processor meets the requirements of 21 CFR Part 108 and Part 113 or 114. (Note: The manufacturer or its authorized representative should provide the requested documentation in English; otherwise, it may result in a delay for consideration of removal.)
PRODUCT: Low-Acid Canned Foods and Acidified Foods PRODUCT CODE: See Red List PROBLEM: Inadequate process control
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate acidification. [Adulteration, 402(a)(4)]." OASIS charge code - NEEDS ACID and/or "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing. [Adulteration, 402(a)(4)]." OASIS charge code - INSANITARY
Arytza SRL
Calle Pedro De Jerez 407 Uf 1 , Girardot 1523
Notes:All Acidified Foods; 03 - - - -- Bakery Prod/Dough/Mix/Icing
Notes:All Acidified Foods; 04 - - - -- Macaroni/Noodle Prod
Notes:All Acidified Foods; 05 - - - -- Cereal Prep/Breakfast Food
Notes:All Acidified Foods; 07 - - - -- Snack Food Item
Notes:All Acidified Foods; 09 - - - -- Milk/Butter/Dried Milk Prod
Notes:All Acidified Foods; 12 - - - -- Cheese/Cheese Prod
Notes:All Acidified Foods; 13 - - - -- Ice Cream Prod
Notes:All Acidified Foods; 14 - - - -- Filled Milk/Imit Milk Prod
Notes:All Acidified Foods; 15 - - - -- Egg/Egg Prod
Notes:All Acidified Foods; 16 - - - -- Fishery/Seafood Prod
Notes:All Acidified Foods; 17 - - - -- Meat, Meat Products and Poultry
Notes:All Acidified Foods; 18 - - - -- Vegetable Protein Prod
Notes:All Acidified Foods; 20 - - - -- Fruit/Fruit Prod
Notes:All Acidified Foods; 21 - - - -- Fruit/Fruit Prod
Notes:All Acidified Foods; 22 - - - -- Fruit/Fruit Prod
Notes:All Acidified Foods; 23 - - - -- Nuts/Edible Seed
Notes:All Acidified Foods; 24 - - - -- Vegetables/Vegetable Products
Notes:All Acidified Foods; 25 - - - -- Vegetables/Vegetable Products
Notes:All Acidified Foods; 26 - - - -- Vegetable Oils
Notes:All Acidified Foods; 27 - - - -- Dressing/Condiment
Notes:All Acidified Foods; 28 - - - -- Spices, Flavors And Salts
Notes:All Acidified Foods; 29 - - - -- Soft Drink/Water
Notes:All Acidified Foods; 30 - - - -- Beverage Bases/Conc/Nectar
Notes:All Acidified Foods; 31 - - - -- Coffee/Tea
Notes:All Acidified Foods; 32 - - - -- Alcoholic Beverage
Notes:All Acidified Foods; 33 - - - -- Candy W/O Choc/Special/Chew Gum
Notes:All Acidified Foods; 34 - - - -- Choc/Cocoa Prod
Notes:All Acidified Foods; 35 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling
Notes:All Acidified Foods; 36 - - - -- Food Sweeteners (Nutritive)
Notes:All Acidified Foods; 37 - - - -- Mult Food Dinner/Grav/Sauce/Special
Notes:All Acidified Foods; 38 - - - -- Soup
Notes:All Acidified Foods; 39 - - - -- Prep Salad Prod
Notes:All Acidified Foods; 40 A - - -- Baked Goods (Baby)
Notes:All Acidified Foods; 40 B - - -- Cereal (Baby)
Notes:All Acidified Foods; 40 D - - -- Veg (Baby)
Notes:All Acidified Foods; 40 E - - -- Fruit/Juice/Drink (Baby)
Notes:All Acidified Foods; 40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Notes:All Acidified Foods; 40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Notes:All Acidified Foods; 40 H - - -- High Meat Dinner/Cheese Food (Baby)
Notes:All Acidified Foods; 40 I - - -- Fish-Seafood Prod (Baby)
Notes:All Acidified Foods; 40 J - - -- Egg Prod (Baby)
Notes:All Acidified Foods; 40 K - - -- Pudding/Custard (Baby)
Notes:All Acidified Foods; 40 L - - -- Soups/Soup Mix (Baby)
Notes:All Acidified Foods; 40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Notes:All Acidified Foods; 40 X - - -- Market Basket Sampling
Notes:All Acidified Foods; 40 Y - - -- Baby Food N.E.C.
Notes:All Acidified Foods; 41 - - - -- Dietary Conv Food/Meal Replacements
Notes:All Acidified Foods; 52 B - - 06 Corn Husks (Food Related)
Notes:All Acidified Foods; 52 B - - 07 Snail Shells (Food Related)
Notes:All Acidified Foods; 52 B - - 08 Sausage Casings, Artificial (Food Related)
Notes:All Acidified Foods; 52 B - - 12 Bird's Nest
Notes:All Acidified Foods; 52 D - - -- Live Animals
Notes:All Acidified Foods; DULCIORA S.A.
Ruta 148, km 756 , Villa Mercedes,
20 - - E -- Fruit/Fruit Prod
Desc:All LACF food products Notes: 21 - - E -- Fruit/Fruit Prod
Desc:All LACF food products Notes: 24 - - E -- Vegetables/Vegetable Products
Desc:All LACF food products Notes: 25 - - E -- Vegetables/Vegetable Products
Desc:All LACF food products Notes: 25 - - F -- Vegetables/Vegetable Products
Desc:All LACF food products Notes: BELGIUM
Desc:NATURAL WHITE BEANS PACKED IN WATER Notes: - TINPLATE/STEEL (208x301; 214x405; 314x411; 600x601) Reason; INADEQUATE - PROC ; ; 09/10/2009 24 A E E 10 Navy (White) Beans, (Baked Beans, Pork & Beans)
Desc:BAKED BEANS IN TOMATO SAUCE Notes: CAN - TINPLATE/STEEL (208x301; 214x405; 314x411; 600x601) Reason; INADEQUATE - PROC; ;09/10/2009 24 A E E 14 Stringbeans
Desc:CUT STRINGLESS BEANS GREEN PACKED IN WATER Notes: CAN - TINPLATE/STEEL (208x301; 214x405; 314x411; 600x601) Reason; INADEQUATE - PROC; ; 09/10/2009 24 A E E 17 Pigeon Peas
Desc:PEAS PACKED IN WATER Notes: CAN - TINPLATE/STEEL (208x301; 214x405; 314x411; 600x601) Reason; INADEQUATE - PROC ; ; 09/10/2009 24 A E E 99 Beans, Corn, and Pea, N.E.C. (Vegetable)
Desc:GREEN FLAGEOLETS BEANS PACKED IN WATER Notes: CAN - TINPLATE/STEEL (214x405; 314x411) Reason; INADEQUATE - PROC ; ; 09/10/2009 24 T E E 11 Celery (Leaf & Stem Vegetable)
Desc:CELERY HEARTS; PACKED IN WATER Notes: CAN - TINPLATE/STEEL (214x405; 314x411; 600x601) Reason; INADEQUATE - PROC ; ;09/10/2009 24 T E E 11 Celery (Leaf & Stem Vegetable)
Desc:CUT CELERY; PACKED IN WATER Notes: CAN - TINPLATE/STEEL (214x405; 314x411; 600x601) Reason; INADEQUATE - PROC ;09/10/2009 25 E E E 02 Carrots and Peas (Sweet) (Mixed Vegetables)
Desc:PEAS & WHOLE CARROTS (PEAS; CARROTS) PACKED IN WATER Notes: CAN - TINPLATE/STEEL (208x301; 214x405; 314x411; 600x601) Reason; INADEQUATE - PROC ; ;09/10/2009 25 E E E 03 Corn and Peppers (Mixed Vegetables)
Desc:MIXED VEGETABLES (CUT CARROTS; CUT BEANS; PEAS; TURNIPS; GREEN FLAGEOLET BEANS) PACKED IN WATER Notes: ; CAN - TINPLATE/STEEL (208x301; 214x405; 314x411; 600x601) Reason; INADEQUATE - PROC ; ;09/10/2009 25 J E E 01 Carrot (Root & Tuber Vegetable)
Desc:CUT AND WHOLE BELGIAN CARROTS PACKED IN WATER Notes: CAN - TINPLATE/STEEL (208x301; 214x405; 314x411; 600x601) Reason; INADEQUATE - PROC ; ;09/10/2009 N.V.G. Maertens
24 A E E 14 Stringbeans
Desc:GREEN BEANS (WHOLE AND CUT) IN BRINE Notes: CAN - TINPLATE/STEEL (603x601) Reason; INADEQUATE - PROC ; ;09/10/2009 24 A E E 17 Pigeon Peas
Desc:EARLY JUNE PEAS Notes: CAN - TINPLATE/STEEL (300x407) Reason; INADEQUATE - PROC ; ;09/10/2009 24 A E E 17 Pigeon Peas
Desc:PEAS GARDEN IN BRINE Notes: CAN - TINPLATE/STEEL (603x700) Reason; INADEQUATE - PROC ; ;09/10/2009 24 A E E 51 Peas
Desc:FRESH GARDEN PEAS; EXTRA FINE;VERY FINE; FINE; HALF FINE Notes: CAN - TINPLATE/STEEL (603x601; 603x909) Reason; INADEQUATE - PROC ; ;09/10/2009 24 A E E 51 Peas
Desc:FRESH GARDEN PEAS; EXTRA FINE;VERY FINE; FINE; HALF FINE; Notes: CAN - TINPLATE/STEEL (300x405, 401x410) Reason: INADEQUATE - PROC; : 09/10/2009 24 A E E 99 Beans, Corn, and Pea, N.E.C. (Vegetable)
Desc:GREEN FLAGEOLETS Notes: CAN - TINPLATE/STEEL (300x407) Reason; INADEQUATE - PROC ; ;09/10/2009 24 T E E 07 Brussels Sprouts (Leaf & Stem Vegetable)
Desc:BRUSSELS SPROUTS Notes: CAN - TINPLATE/STEEL (300x407; 603x608) Reason; INADEQUATE - PROC ; ;09/10/2009 24 T E E 11 Celery (Leaf & Stem Vegetable)
Desc:CELERY ROOT JULIENNE Notes: CAN - TINPLATE/STEEL (603x608) Reason; INADEQUATE - PROC; ;09/10/2009 24 T E E 11 Celery (Leaf & Stem Vegetable)
Desc:CELERY HEARTS Notes: CAN - TINPLATE/STEEL (300x407; 401x411; 603x608) Reason; INADEQUATE - PROC ; ;09/10/2009 24 T E E 11 Celery (Leaf & Stem Vegetable)
Desc:CELERY ROOT JULIENNE; Notes: CAN - TINPLATE/STEEL (600x601) Reason; INADEQUATE - PROC ; ;09/10/2009 24 T E E 11 Celery (Leaf & Stem Vegetable)
Desc:CELERY HEARTS; 3 UP TO 4 STALKS PER TIN Notes: CAN - TINPLATE/STEEL (600x601) Reason; INADEQUATE - PROC ; ;09/10/2009 25 J E E 01 Carrot (Root & Tuber Vegetable)
Desc:SLICED CARROTS- SHOESTRING STYLE (CARROTS; SUGAR; WATER) Notes: CAN - TINPLATE/STEEL (600x601) Reason; INADEQUATE - PROC ; ;09/10/2009 25 J E E 01 Carrot (Root & Tuber Vegetable)