Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ps-ravioli-company-08042015
Timestamp: 2019-09-18 01:48:19
Document Index: 326205229

Matched Legal Cases: ['art 123', 'art 110', 'art 123', '§ 342', '§ 343', 'art 101', '§ 343', '§ 321', '§343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§ 379', '§ 379']

P&S Ravioli Company - 08/04/2015 | FDA
P&S Ravioli Company - 08/04/2015
P&S Ravioli Company August 04, 2015
15-PHI-18
Mr. Franco DiGiacomo, President
2001 S. 26th Street
Philadelphia, PA 1914 7
Dear Mr. DiGacomo:
We inspected your processing facility, located at 2001 S. 26th Street, Philadelphia, PA on January 7-16, 2015. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Points (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. Accordingly, your Lobster Ravioli product is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
In addition, after review of your product labels, we found that your Jumbo Lobster Ravioli, Cheese Tortellini, Linguine, Alfredo Sauce, and Tomato Sauce products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and Title 21, Code of Federal Regulations (CFR) Part 101. You may find the Act, the seafood HACCP regulation, the food labeling regulations, and the Fish and Fisheries Products Hazards & Controls Guidance: 4th Edition (the Hazard Guide), through links in the FDA's home page at www.fda.gov.
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c) (1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for your Lobster Ravioli product does not list the food safety hazards of Clostridium botulinum growth and toxin formation at the "Defrosting of Lobster Meat" critical control point (CCP), during the storage of unopened vacuum packaged cooked seafood in the walk-in refrigerator prior to manufacturing.
Once you have identified hazard(s), you must take steps necessary to control them. We recommend that you refer to Chapter 13 (Clostridium botulinum Toxin Formation) of the Hazards Guide for information on recommended control strategies related to Clostridium botulinum for both refrigerated and frozen products. You can find the Hazards Guide at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm
2. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, regarding your corrective action plan for your Lobster Ravioli product:
a. At the "Defrosting of Lobster Meat" CCP, you indicate "If temp exceeds (b)(4) and refrigerator is broken. The refrigerator will be fixed." However, this corrective action is inadequate in that it fails to describe how the affected products will be evaluated if the temperature CL is exceeded and how you will prevent further deterioration of the product.
b. At the "Making of Lobster Ravioli" CCP, you indicate "If process takes longer than (b)(4). And the temperature of the lobster filling reaches above (b)(4) for more than (b)(4). The filling will be placed in the freezer until the temperature drops to a safe limit in which the production process can be finished." However, this corrective action is inadequate in that it fails to address how to prevent reoccurrence of the deviation. Further, it fails to describe how the affected products will be evaluated. In addition, this is a repeat deficiency from the FDA inspections ending on March 17, 2010 and September 17, 2009.
3. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points (CCP), to comply with 21 CFR 123.6( a) and (c)(2). A CCP is defined in 21 CFR 123.3(b) as a point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels. However, your firm's HACCP plan for Lobster Ravioli does not list the CCP of "Finished Product Labeling" for controlling the food safety hazard of undeclared major food allergens.
4. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring/frequency procedures of continuous temperature monitoring of the walk-in refrigerator at the "Defrosting of Lobster Meat" CCP to control the hazard of pathogen growth and toxin formation, for your Lobster Ravioli product. Specifically, our investigators were informed that, in practice, the refrigerator temperature is documented (b)(4) when the firm is operating and is not documented when the firm is closed. As stated in observation #2 above, your firm defrosts unopened vacuum-packed cooked seafood in the refrigerator for up to (b)(4) days before manufacturing. In addition, this is a repeat deficiency from the FDA inspections ending on March 17, 2010 and as of the date of this letter, continuous monitoring of your refrigerator is not been implemented.
5. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11 (b), to comply with 21 CFR 123.11(c). However, your firm does not maintain sanitation monitoring records for Maintenance of hand washing, hand sanitizing, and toilet facilities; 2) protection of food, food packaging material, and food contact surfaces from adulteration; and (3) proper labeling, storage, and use of toxic compounds. Specifically,
a. Your sanitation checklist for Lobster Ravioli processing does not address maintenance of hand washing and toilet facilities; protection from adulteration; or proper labeling, storage, and use of toxic compounds. For example, the checklists for the manufacturing of Lobster Ravioli on (b)(4) fail to document the monitoring of these areas.
b. Your sanitation checklist for Lobster Ravioli processing has not been completed since (b)(4). Lobster Ravioli was manufactured on (b)(4).
Additionally, Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. Are-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of there-inspection and assessing and collecting there-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Sanitation Deviations:
1. Your firm failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food-contact surfaces, to comply with 21 CFR 110.35(a). Specifically, on January 8, 2015, our investigator observed an employee using a high pressure air device to clean manufacturing equipment and the floor in the production room. This area was (b)(4) from exposed food, including Pecorino Romano cheese. Blown particles were observed in the immediate area of this cheese, which was used in the manufacturing of Cheese Ravioli on January 13,2015.
2. Your firm failed to have employees remove unsecured jewelry or other objects which might fall into food, to comply with 21 CFR 110.10(b)(4). Specifically, on January 8, 2015, our investigator observed:
a. An employee wearing rings containing stones while packaging Alfredo Sauce and Cheese Ravioli
b. An employee, working at the dough sheeter, was wearing a hat that failed to cover a hoop earring while he was manufacturing Cheese Ravioli.
c. An employee was wearing a hair net that failed to cover a hoop earring while packaging Cheese Tortellini.
3. Your firm failed to have an employee wear a beard cover, where appropriate, to comply with 21 CFR 110.10(b)(6). Specifically, on January 8, 2015, our investigator observed an employee working at the ravioli machine that was not wearing a beard net to cover his mustache.
1. Your Cheese Tortellini, Linguine, Alfredo sauce, and Jumbo Lobster Ravioli products are misbranded within the meaning of Section 403(w) of the Act, [21 U.S.C. § 343(w)j, in that the finished product labels fail to declare the major food allergens as required by section 403(w)(1) of the Act.
Section 201 (qq) of the Act [21 U.S. C. § 321 (qq)J, defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils as "major food allergens". A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
• The word "Contains;" followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. §343(w)(1)(A)J; or
• The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., "Whey (Milk)'?, except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C.§ 343(w)(1)(B)j.
The products noted below are manufactured from ingredients that contain major food allergens, however, the presence of allergens are not declared in accordance with the requirements for F ALCP A which can be met by either declaring the allergen in the ingredient statement or by using a "Contains" statement:
• Your Cheese Tortellini and Linguine products are made with "Enriched Extra Fancy Durum Flour" but, fail to declare the allergenic ingredient, "wheat" in the ingredient statement. In addition, the allergen statements on both labels include "flour"; we note that this is not an acceptable name of the food source under FALCPA.
• Your Alfredo Sauce product contains heavy cream and butter, but the ingredient statement fails to declare the allergenic ingredient, "milk".
• The "Contains" statement on the Jumbo Lobster Ravioli label is incorrect because the ingredient is (b)(4), rather than "lagastino lobster."
• The "Contains" statement on the Jumbo Lobster Ravioli label declares "soybean oil" as the name of the food source from which the allergen is derived. We note that under F ALCP A, the name of the food source is "soybeans." Acceptable synonyms include "soy," "soya" and "soybean." (See Food Labeling Guide, question F12)
• The cheese tortellini, jumbo lobster ravioli, and linguine labels list allergens preceded by "Food Allergens." We note that FALCPA does not provide for this declaration. Under FALCPA, the word "Contains" must be used.
2. Your Jumbo Lobster Ravioli product is misbranded within the meaning of sections 403(a)(1) [21 U.S.C. § 343(a)(l)] and 403(b) [21 U.S.C. § 343(b)] of the Act. The name "lobster" without qualification refers to the Homarus species of lobster, commonly known as American or European lobster. During the inspection, our investigators determined that the lobster ingredient used to manufacture the filling for your Jumbo Lobster Ravioli product is derived from the species (b)(4), which is substantially smaller than American (Homarus americanus) or European lobster (Homarus gammarus). Although (b)(4). is in the same family (Nephropidae) as Homarus spp., (b)(4) is a different species than the species commonly known and marketed as American or European lobster, or as "lobster" unqualified. Therefore, a statement that meat from (b)(4) is "Lobster" is false and causes it to be sold under the name of another food.
We further note that section 403(i)(1) [21 U.S.C. § 343(i)(l)] of the Act requires the label of a food to bear the common or usual name of the food. In the absence of a common or usual name, a food in packaged form should bear a statement of identity in terms of an appropriately descriptive term (see 21 CFR 101.3(b)). The agency believes that an appropriate statement of identity and market name for your product would be "(b)(4) Lobster Ravioli" or "(b)(4) Ravioli." These names are provided in The Seafood List, FDA's Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce. More information about The Seafood List can be found in FDA's Guidance for Industry: The Seafood List- FDA's Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce, which is available on our website at: http://www.accessdata.fda.gov/scripts/fdcc/?set=seafoodlist
3. Your Jumbo Lobster Ravioli, Cheese Tortellini, and Linguine products are misbranded within the meaning of section 403(a)(l) of the Act [21 U.S.C § 343(a)(1)] in that their labels are a false and misleading representation of the products. Specifically, the labels bear the claims "All Natural" and/or "nothing artificial." We consider use of the term "natural" on a food label to be truthful and non-misleading when "nothing artificial or synthetic ... has been included in, or has been added to, a food that would not normally be expected to be in the food." [58 FR 2302, 2407, January 6, 1993]. Your Cheese Tortellini and Linguine products contain thiamine mononitrate, and your Jumbo Lobster Ravioli contain folic acid. Thiamine mononitrate and folic acid are not naturally occurring substances in foods and are produced synthetically. Therefore, the claim "All Natural" on your Cheese Tortellini and the statement that "nothing artificial" is added to your Jumbo Lobster Ravioli and Linguine are false or misleading and cause these food products to be misbranded.
4. Your Jumbo Lobster Ravioli, Cheese Tortellini, Alfredo Sauce, Tomato Sauce, and Linguine products are misbranded under Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but their labels fail to bear the common or usual name of each ingredient, as required by 21 CFR 101.4 and fail to declare all sub-ingredients (ingredients of an ingredient in a finished product), as required by 21 CFR 101.4(b)(2):
• Jumbo Lobster Ravioli
o The label fails to accurately declare the sub-ingredients of the ricotta cheese. Specifically, the Jumbo Lobster Ravioli label declares the ingredients cream, skim milk, vinegar and stabilizers which are not declared on the ricotta cheese ingredient label. In addition, the Jumbo Lobster Ravioli label fails to declare the ingredient "starter" which is declared on the ricotta label. The sub-ingredients declared for the Pecorino Romano cheese includes "cultures"; however, this is not an ingredient in the Pecorino Romano cheese based on the label provided.
o The ingredient declaration incorrectly includes langostino lobster meat. The actual ingredient is (b)(4) or (b)(4) lobster meat.
o Title 21 CFR 101.4 does not provide for "may contain" or "and/or" labeling for sesame or poppy seeds. If these ingredients are used, they must be declared in the ingredient list. If they are not ingredients, they must not be included in the ingredient list.
o The label fails to declare the sub-ingredients contained in the Enriched Extra Fancy Durum Wheat Flour of milled wheat, iron, and folic acid, as required by 21 CFR 101.4(b)(2) and (b)(15). The label also declares ferrous sulfate as a sub-ingredient of the enriched durum flour; however, the enriched durum flour ingredient label does not list that ingredient.
o The label fails to declare "enzymes"; however, the Pecorino Romano cheese ingredient label declares this as an ingredient. In addition, the label declares "cultures" as a sub-ingredient of the Pecorino Romano cheese; however, this is not an ingredient declared on the Pecorino Romano cheese ingredient label.
o The cheese tortellini label declares pasteurized part skim milk as a sub-ingredient of the mozzarella cheese; however, the label of the mozzarella cheese used to make the cheese tortellini declares pasteurized milk (whole milk) as an ingredient.
o Based on the ingredient label we were provided for the mozzarella cheese (PDP was not provided, only the ingredient listing), the mozzarella is made with low moisture mozzarella cheese which is a standardized food under 21 CFR 133.156. However, this ingredient is not declared in accordance with 21 CFR 101.4 because it is declared as "mozzarella cheese" which is not the appropriate name of this ingredient.
o The product contains the ingredient Pecorino Romano Cheese; however, the label fails to declare the sub-ingredients contained in the Pecorino Romano Cheese of Sheep's milk, salt, and rennet, as required by 21 CFR 101.4(b)(2).
o The ingredient declaration "vegetable ... oil" is not in accordance with CFR 101.4(b)(14). Also "meat stock" is not an appropriate common or usual name under 21 CFR 101.4.
o The label declares ferrous sulfate as a sub-ingredient of the enriched durum flour; however, the enriched durum flour ingredient label does not list that ingredient. In addition, the label fails to declare folic acid, milled wheat and iron as sub-ingredients of the enriched durum flour in accordance with 21 CFR 101.4.
The requirement to list component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food [21 CFR 101.4(b)(2)].
5. Your Tomato Sauce and Alfredo Sauce products are misbranded within the meaning of section 403(e)(l) of the Act [21 U.S.C. § 343(e)(1)] in that the packages do not contain the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(a).
For additional information on General Food Labeling requirements go to: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatmylnformation/LabelingNutrition/default.htm
We also have the following comments in regards to your Seafood HACCP:
• You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.8(a)(l). However, your firm did not reassess your Lobster Ravioli HACCP plan at least annually, to assure that it adequately controls all identified hazards. Specifically, your HACCP plan for Lobster Ravioli has not been reassessed since (b)(4).
• You must have an individual associated with your firm who has successfully completed training in the application of HACCP principles to fish and fishery product processing at least equivalent to that received under standardized curriculum recognized as adequate by the FDA, or is otherwise qualified through job experience, as required by 21 CFR 123.10. As of January 16, 2015, no one associated with your firm was found to have been adequately trained. Further, this is a repeat deficiency from the FDA inspections ending on March 17, 2010 and September 17, 2009.
• Your firm failed to store food away from toxic cleaning compounds and sanitizing agents in a manner that protects against contamination of food, as required by 21 CFR 110.35(b)(2). Specifically, on January 7, 2015, our investigator observed vegetable oil stored on a shelf in the dish washing area of the productions room, immediately adjacent to chlorine sanitizer solutions. We acknowledge that the food product was moved and that you stated that food would not be stored with cleaning compounds in the future.
• Your firm failed to have employees wash hands thoroughly and sanitize if necessary to protect against contamination with undesirable microorganisms, at any time when the hands may have become soiled or contaminated, to comply with 21 CFR 110.10(b)(3). Specifically, on January 8, 2015, our investigator observed an employee pushing a wheeled cart enter the production room from the warehouse and begin manually packaging finished product Cheese Ravioli, without washing his hands.
• Your firm failed to store cleaned and sanitized equipment in a location and manner that protects food-contact surfaces from contamination, as required by 21 CFR 110.35(e). Specifically, on January 8, 2015, our investigator observed an employee washing plastic trays which are used for holding pasta products. After the trays were cleaned and sanitized, the employee rested a stack of the trays on the floor against her leg, as she loaded the drying rack.
In addition, we have the following comments regarding your labeling:
o The label states "So enjoy the quality line of P&S products, and you will experience the quality, freshness, and tradition we have combined to bring you the finest pasta that ever graced your table." The pasta is labeled "Keep Frozen Until Ready To Use" and contains a processed ingredient (e.g., "Pasteurized Whole Eggs"). Under 21 CFR 101.95(a), the term "fresh," when used on the label or in labeling of a food in a manner that suggests or implies that the food is unprocessed, means that the food is in its raw state and has not been frozen or subjected to any form of thermal processing or any other form of preservation. Because the product is frozen and contains a processed ingredient, we question whether the product should be characterized as "fresh."
o We question the truth of the statement "meat stock removed before packaging." If the sauce is simmered in meat stock, we question how it would be possible to completely separate and remove it from another liquid.
o We note that the serving size is not declared in accordance with 21 CFR 101.12(c). The label declares the serving size as "1 cup cooked (114g uncooked)." Under 21 CFR 101.12(c), if a product requires further preparation, e.g., cooking or the addition of water or other ingredients, and if 21 CFR 101.12(b) provides a reference amount for the product in the prepared but not the unprepared form, then the reference amount for the unprepared product shall be the amount of the unprepared product required to make the reference amount for the prepared product as established in 21 CFR 101.12(b). Because the reference amount customarily consumed (RACC) in 21 CFR 101.12(b) for a mixed dish measure able with a cup is 1 cup, the serving size should be the amount of uncooked ravioli needed to prepare 1 cup of cooked ravioli. We note that if there is a difference between the serving size currently declared and the correct serving size, the nutrition information may need to be revised also.
o We note that the ricotta ingredient label declares "starter" while the cheese tortellini label declares "milk culture." We question whether "milk culture" is the appropriate name for this ingredient. Under 21 CFR 101.4(b)(5) "cultured milk" could be used. As stated above, "starter," is not an appropriate common or usual name for any ingredient.
o The ingredient list appears on a different panel than the nutrition information and name and place of business. Under 21 CFR 101.2(d)(l), all information required to appear on the principal display panel or on the information panel under this section shall appear on the same panel unless there is insufficient space. In determining the sufficiency of the available space, except as provided by 101.9(j)(17) and 101.36(i)(5), any vignettes, designs, and other non-mandatory label information shall not be considered.
Further, Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. Are-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of there-inspection and assessing and collecting there-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
P&S Ravioli Company - Close Out Letter 6/28/16