- Casa di Pasta, Inc.
- Issuing Office:
- Baltimore District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive
Baltimore, MD 21201-2199
Telephone: (410) 779-5455
FAX: (410) 779-5705
RETURN RECEIPT REQUESTED
July 23rd, 2014
Mr. Frank M. Velleggia, Owner
Casa di Pasta, Inc.
210 Albemarle Street
Baltimore, MD 21202
Dear Mr. Velleggia:
Investigators from the Baltimore District Office of the U.S. Food and Drug Administration conducted an inspection of your facility located at 210 Albemarle Street, Baltimore, MD on March 18, 2014; March 27, 2014; and April 10, 2014.
During our inspection your firm was found to have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products 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 fish or 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 Seafood Ravioli products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov
Additionally, review of your labels for Seafood Ravioli and Cheese Ravioli revealed violations that render these products misbranded within the meaning of section 403 of the Act [21 U.S. C.§ 343].
Your significant violations include but are not limited to the following:
Seafood HACCP Violations
1. Your firm 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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a), and (b). However, your firm does not have a HACCP plan for your Seafood Ravioli to control the food safety hazards of pathogenic growth and toxin formation, and undeclared allergens.
2. Your firm must monitor the sanitation conditions and practices during processing with sufficient frequency to ensure compliance with Current Good Manufacturing Practices in 21 CFR Part 110 to comply with 21 CFR 123.11(b). However, your firm did not monitor the safety of water that comes into contact with food or food contact surfaces, the condition and cleanliness of food contact surfaces, and the prevention of cross-contamination from insanitary objects as evidenced by:
a. A three (3) compartment sink used to clean and sanitize food-contact surfaces did not have an air gap between the sink and the floor drain.
b. The dough laminator machine and small dough machine had buildups of dough from previous batches of pasta produced after the sanitation process was completed.
c. Marinara sauce was stored uncovered in between metal shelves that are uncleanable and that appear to be coated in a rust-like flaking substance.
1. Your Cheese Ravioli product is misbranded within the meaning of section 403(w) of the Act [21 U.S. C.§ 343(w)] in that the label fails to declare all major food allergens present in the product, as required by section 403(w)(1) of the Act.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines "major food allergens" as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans; as well as any food ingredient containing protein derived from one of these foods, with certain exceptions, e.g. highly refined oils derived from a major food allergen. 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:
a. The word "Contains," followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [Section 403(w)(1)(A) of the Act; 21 U.S.C. § 343(w)(1)(A)]; or
b. 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., "Enriched Flour (Wheat)"), 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)].
Specifically, your Cheese Ravioli product is manufactured using extra fancy (b)(4) flour and (b)(4) flour, which are types of wheat flour; however, your label fails to declare the major food allergen wheat.
We acknowledge that you initiated corrections to your labels for products manufactured after 3/18/2014 during the inspection. However, your corrections are inadequate because you should declare all allergens if you choose to use the “Contains” statement. Specifically, your corrected label for the Stuffed Shells in Marinara product fails to include the major allergen milk in the “Contains” statement.
2. Your Seafood Ravioli and Cheese Ravioli products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because they are fabricated from two or more ingredients, but the labels fail to bear a complete list of ingredients by common or usual name, as required by 21 CFR 101.4.
Specifically, (b)(4) cheese and (b)(4) cheese are used in the manufacturing of your Seafood Ravioli and Cheese Ravioli products. The ingredients (b)(4) cheese and (b)(4) cheese are standardized foods that consist of two or more ingredients; however, your labels only declared the milk sub-ingredient for (b)(4) cheese and no sub-ingredients listed for the (b)(4) cheese.
In addition, the (b)(4) seasoning you use in the manufacturing of the Seafood Ravioli product is the trade name of a multicomponent food; however, your label fails to declare the sub-ingredients for the (b)(4) seasoning.
3. Your Seafood Ravioli and Cheese Ravioli products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that they fail to bear the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You are responsible for ensuring that your processing plant operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.
Additionally, we have the following comments:
- If your firm uses more than one recipe for the Seafood Ravioli product, you must have an accurate label for each formula that you use. If lobster is added as an ingredient to the Seafood Ravioli product, it must be listed on the label in accordance with the requirements in 21 CFR 101.4.
- Your Seafood Ravioli, Cheese Ravioli, and Stuffed Shells in Marinara products lack nutrition labeling in accordance with 21 CFR 101.9.
- The outer containers for your Seafood Ravioli and Cheese Ravioli products sold to individual customers do not provide an accurate statement of the quantity of contents, as required under 21 CFR 101.105. Specifically, our investigators observed that you only affix a sticker label on the outer case but no label is affixed to the individual trays of pasta products. In addition, we note that the net weight of “14 oz.” declared on the Seafood Ravioli and Cheese Ravioli product label appears to be an inaccurate net weight for a case of 4 trays of pasta products. If the individual trays are intended to be sold separately at retail, they are required to bear mandatory label information unless they meet the requirements for exemption under 21 CFR 101.100(a)(2).
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 reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as verification records and revised labeling, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
If you have any questions regarding the contents of this letter, please contact David Rice, Compliance Officer at 410-779-5463.
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