- Oliverio's Italian Style Peppers, Inc.
- Issuing Office:
- Baltimore District Office
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707
July 19, 2016
Return Receipt Requested
Mr. Mark F. Oliverio, President
Oliverio’s Italian Style Peppers, Inc.
280 Ohio Avenue
Clarksburg, WV 26301
Dear Mr. Oliverio:
Between March 14 and 18, 2016, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 334 Stiles Street, Clarksburg, WV. The inspection revealed that your firm manufactures acidified food products. The inspection also revealed that you have serious deviations from regulations for acidified foods (Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108) and Part 114, Acidified Foods (21 CFR Part 114)). Accordingly, we have determined that your firm’s acidified food products are 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)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
As an acidified foods processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and current good manufacturing practices. The Emergency Permit Control regulation was issued, in part, pursuant to section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and mandatory requirements of 21 CFR Part 114.
Additionally, your products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and its implementing regulations under Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and the Acidified Food and Food Labeling regulations through links in FDA’s home page at http://www.fda.gov
We acknowledge your written response, dated March 21, 2016, to the Form FDA 483, List of Inspectional Observations that was issued to your firm at the conclusion of our inspection. We have reviewed your response and concluded that it lacks sufficient corrective actions. Our comments are listed below.
Acidified Food Adulteration
1. As a commercial processor in the thermal processing of acidified foods you must, (b)(3)(B) prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). However, our inspection revealed you failed to file a scheduled process with FDA for your firm’s (b)(4) MEDIUM HOT PEPPERS & ONIONS With Tomato Sauce. You have been manufacturing this product using your firm’s Peppers in Sauce formulation and process, which has been determined to be an acidified food product by your process authority, with the exception of the addition of onions. The process authority letter for your Peppers in Sauce products states that the “review is only for this product produced in exactly the same manner, same ratios and same containers”. Therefore, your firm failed to have your scheduled process for your (b)(4). MEDIUM HOT PEPPERS & ONIONS With Tomato Sauce product established by a qualified person who has expert knowledge acquired through appropriate training and experience in manufacturing of acidified foods, as required by 21 CFR 114.83.
Your firm’s response states that “a scheduled process will be documented for all (b)(4) products immediately”; however, at this time there has been no new process filing submitted to FDA for this product and there is no assurance that your process authority will approve the formulation and process that you have established.
Scheduled process information for acidified foods must be submitted on Form FDA 2541e (Food Process Filing for Acidified Method). More information on registration and filing can be found in the publication “Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format” available at: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm309376.htm
2. Your firm failed to ensure that each food is manufactured in accordance with the scheduled process as required by 21 CFR 114.80(a)(1). Specifically, the scheduled process for Hot Peppers in Sauce was not followed in that your Oliverio Hot PEPPERS in Sauce Olvero, 16 oz jars (b)(4) and (b)(4) Super Select Hot PEPPERS AND SAUCE, 16 oz jars (b)(4) products, manufactured on March 14, 2016 lists vinegar as an ingredient. However, vinegar was not used during the manufacture of these products and instead the tomato ingredients are the acidifying agent in your products. We also note that your process authority letter states that your pH values are very close to (b)(4) and that they highly recommend (b)(4) the amount of (b)(4) to achieve a pH around (b)(4).
Your firm’s response states that you will work with your process authority to correct these violations; however, at this time, we have not received any updated scheduled process submissions from your firm. In addition, please note that if you make any intentional changes to your firm’s filed scheduled process (i.e. changing ingredients or method of heat treatment), you must have that new process evaluated by your process authority and updated process filings must be filed with FDA in accordance with 21 CFR 108.25(a)(2).
1. Your Medium Hot Peppers & Onions with Tomato Sauce, Hot Peppers in Sauce Olvero, and Super Select Hot Peppers and Sauce products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format. Specifically,
- The Hot Peppers & Onions with Tomato Sauce and Hot Peppers in Sauce Olvero products labels declare a serving size of 1 oz. (28g) and the Super Select Hot Peppers and Sauce product label declare a serving size of 2 oz. (57g). However, the Referenced Amount Customarily Consumed (RACC) for this type of product is 110 grams [21 CFR 101.12(b)], Table 2, “Vegetables: All other vegetables with sauce.” Therefore, the serving size is not correctly determined from the RACC; hence, all of the nutrient information is incorrectly declared.
- The serving size is not expressed in common household measure that is appropriate to the food [21 CFR 101.9(b)(5)].
- The Medium Hot Peppers & Onions with Tomato Sauce product uses the vertical format for the Nutrition Facts label but has an incomplete footnote as required in 21 CFR 101.9(d)(9). Under 21 CFR 101.9(d)(11)(i), if the space beneath the information on vitamins and minerals is not adequate to accommodate the information required in paragraph (d)(9) of this section, the information required in paragraph (d)(9) may be moved to the right of the column required in paragraph (d)(7)(ii) of this section and set off by a line that distinguished it and sets it apart from the percent Dailey Value information.
2. Your Medium Hot Peppers & Onions with Tomato Sauce, Hot Peppers in Sauce Olvero, and Super Select Hot Peppers and Sauce 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 and the product labels fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically,
- According to the product formulations and our investigators’ observation during the inspection, your products are manufactured using sugar; however, you fail to declare this ingredient on your finished product labels.
- The Medium Hot Peppers & Onions with Tomato Sauce and Super Select Hot Peppers and Sauce product labels declare “peppers” in the ingredient statement; however, this is not an appropriate common or usual name for “Bell Peppers” or “Hot Banana Peppers.”
- The Medium Hot Peppers & Onions with Tomato Sauce and Super Select Hot Peppers and Sauce product labels declare vinegar and olive oil in the ingredient statement; however, these ingredients were not added during the manufacturing of these products and therefore must not be declared on the label.
Your written response, dated March 21, 2016, does not include corrective actions for your product labels.
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective action may subject your firm and products to further actions, such as emergency permit control, injunction, or seizure.
We offer you the following labeling comments:
- Your Super Select Hot Peppers and Sauce product label declares an address in Pennsylvania; however the food is not manufactured by the person whose name appears on the label. The name must be qualified by a phrase that reveals the connection such person has with such food, e.g., “Manufactured for_,” “Distributed by _ ,” or any other wording that expresses the facts [21 CFR 101.5(c)].
- The Hot Peppers in Sauce Olvero and Medium Hot Peppers & Onions with Tomato Sauce products declared servings with the word “about.” According to 21 CFR 101.9(b)(8)(i), the term “about” is used for the number of servings between 2 and 5 servings.
- The term “Fat Calories” on the Medium Hot Peppers & Onions with Tomato Sauce and Super Select Hot Peppers and Sauce products is not a permitted abbreviation for “Calories from fat” [21 CFR 101.9U)(13)(ii)(B)].
- The values listed for Calories, Sodium, Carbohydrates, Vitamin A, Vitamin C, Calcium, and Iron for the Hot Peppers in Sauce Olvero and Super Select Hot Peppers and Sauce products are questionable because they are inconsistent even though they are made with the same formulation. For example, the listed serving size for the Super Select Hot Peppers and Sauce product is twice that of the Hot Peppers in Sauce Olvero product, but the Sodium value for the Super Select Hot Peppers and Sauce is 190 mg while the Hot Peppers in Sauce Olvero is 210 mg.
- We question whether the Hot Peppers in Sauce Olvero and Super Select Hot Peppers and Sauce products qualify to use the tabular display with abbreviations and omit the footnote for the Nutrition Facts label since we do not have information on the package size and shape of these products to determine if the total surface area available for labeling is less than 40 square inches.
- The product labels declare “Diced Tomatoes” as an ingredient, but the formulation states “Diced Tomatoes in Puree” and the EIR states that “concentrated crushed tomatoes” are used. We question whether the correct ingredient name is properly declared on the product labels. However, we do not have a label of the ingredient for verification.
- The product formulation includes the addition of water and water is listed as an ingredient on the Hot Peppers in Sauce Olvero product label. However, water is not listed as an ingredient on the Super Select Hot Peppers and Sauce despite the fact that you are utilizing the same formulation. The Medium Hot Peppers & Onions with Tomato Sauce product label also does not include water as an ingredient. We question whether water is actually added during processing according to the formulation and subsequently removed by the heating of the kettle during processing, in which water would not need to be declared as an ingredient (21 CFR 101.100(a)(3)). The firm must determine whether or not the water ingredient in these products must be labeled or not, and then label their products consistently.
- As you may already know, FDA finalized new requirements for nutrition labeling on May 27, 2016. The new Nutrition Facts label includes updates to the required nutrient declarations and formatting requirements. Although, the compliance date will be July 26, 2018 or July 26, 2019 (depending on the size of the manufacturer), manufacturers may begin revising labels now to meet the new requirements. For more information on the new requirements, please see http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm385663.htm.
- The Hot Peppers in Sauce Olvero and Medium Hot Peppers & Onions with Tomato Sauce product labels fail to include the street address of the manufacturer, packer, or distributor. According to 21 CFR 101.5(d), the statement of the place of business must include the street address, unless the street address is shown in a current city directory or telephone directory.
- The word “fresh” in the ingredient statement of the Hot Peppers in Sauce Olvero product is considered intervening material under 21 CFR 101.2(e).
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. A re-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 the re-inspection and assessing and collecting the re-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.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions, such as evidence that you are working with a process authority or your scheduled process has been filed with the FDA. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
Your written response should be sent to Ms. Cherlita Honeycutt, Compliance Officer, U.S. Food and Drug Administration at the above address. If you have questions about this letter, please contact Ms. Honeycutt at 410-779-5412.
Baltimore District Office
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