Mr. Gerald King
- Pakco (Pty) Ltd.
1 Pakco Street
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
FEB 4, 2016
VIA EXPRESS DELIVERY
Mr. Gerald King, Managing Director
Pakco (Pty) Ltd.
1 Pakco Street
P.O. Box 65
Verulam, South Africa.4340
Dear Mr. Gerald King:
The United States Food and Drug Administration (FDA) inspected your facility, Pakco (Pty) Ltd., 1 Pakco Street, Verulam, South Africa, on July 7-8, 20 15. The inspection was conducted to determine your compliance with the Federal Food Drug, and Cosmetic Act (the Act) and regulations that apply to the food you ship to the United States.
During that inspection, we found that your firm had serious deviations from the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR 108)) and Acidified Foods regulation (21 CFR 114). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at the firm. We acknowledge that your firm (b)(3). In addition, we acknowledge receipt of your responses received via email dated July 31, August 11 and October 28, 2015 which included documentation describing corrections to the observations of concern noted on the form FDA-483. However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
As a manufacturer of acidified food (AF) products intended for export to the United States, you are required to comply with the Act and the federal regulations relating to the processing of acidified food products. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR Parts 114. Regulations specific to the processing of acidified food products are described in 21 CFR 108 and 21 CFR 114. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR 114 could be subjected to an immediate application of the emergency permit control provisions of Section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j) for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. Violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR 114 renders your acidified food products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).
Based on our review of your product labels, we have concluded that your aah! Bisto Original, Pakco brand Hot Atchar, Hinds brand Custard Powder, and Pakco brand Chilli Bite Mix products are in violation of the Act and the applicable labeling regulations in Title 21 , Code of Federal Regulations, Part 101 (21 CFR 101) causing these products to be misbranded.
Further, your Hinds brand Custard Powder is adulterated under section 402(c) of the Federal Food. Drug, and Cosmetic Act because it contains color additives which are unsafe within the meaning of section 721(a) of the Act.
You can find copies of the Act and the regulations through links in FDA’s home page at www.fda.gov
Your significant violation is as follows: Your firm failed to, not later than (b)(3), and before packing any new acidified food product, provide the FDA information on the scheduled processes as required by 21 CFR 108.25(c)(2). Specifically, your firm's pickled vegetable products appear to be acidified foods and there are no scheduled processes on file with the FDA for these products. These pickled vegetable products include: Hot Chunky Vegetable Mixed Vegetable, Hot Atchar, Curried Chilies, Brinjal Pickle, and Curried Chili Paste. Your firm is responsible for determining which regulations apply to the products that you manufacture, including whether any of these products are considered to be acidified foods, as defined in 21 CFR 114.3(b), subject to the applicable provisions of 21 CFR parts 108 and 114. Accordingly, your firm should determine or have determined for you whether any additional products that you manufacture are acidified foods, and comply with the applicable requirements of 21 CFR 108 and 114 including registration and process filing for those products that are determined to be acidified foods.
Your Hinds brand Custard Powder product is adulterated under section 402(c) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. §342(c)] because it contains color additives which are unsafe within the meaning of section 721 (a) of the Act. Tartrazine and Sunset Yellow FCF were not certified as FD&C Yellow No. 5 and FD&C Yellow No.6, respectively. FD&C Yellow No. 5 is specifically required to be declared on food product labels under 21 CFR 74.705(d)(2). Ponceau 4R is a non-permitted color additive.
1. Your aah! Bisto Original product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food. For example:
• The aah! Bisto Original product label fails to declare a statement of identity of the food by the common or usual name on the principal display panel as required by 21 CFR 101.3. Statements made on the balance of the product label appear to indicate that the product is a gravy mix.
• The Pakco brand Hot Atchar product label fails to declare a statement of identity of the food by the common or usual name on the principal display panel as required by 21 CFR 101.3. Statements made on the balance of the product label appear to indicate that the product is possibly fermented or pickled vegetables.
2. Your Pakco brand Hot Atchar and Pakco brand Chilli Bite Mix are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For example:
• Your Pakco brand Hot Atchar lists the ingredient "Acidity Regulator [E330]" which is not the common or usual name. Furthermore, there is no provision in the regulations to allow for "vegetables" to be grouped together and there is no provision that allows for "varying proportions" as stated in this ingredient statement.
• Your Pakco brand Chilli Bite Mix lists ingredients such as "Starches (Maize & Wheat) ... Raising agents ... " which are not appropriate common or usual names for the ingredients. "Raising Agents" is also not an appropriate common or usual name. Furthermore, "starches" is not a specific common or usual ingredient name for wheat starch, although it could be used to represent com starch. In addition, there is no provision in the regulation to allow either "starches" or "flours" to be declared collectively. "[F]lour" unqualified is a standardized food name. The specific ingredients, e.g., "pea flour" and "chick pea flour" (if these are the correct ingredients) must be declared individually in descending order of predominance by weight. Finally, the term "Maize" is not an appropriate common or usual name. The common or usual name for "Maize" is corn.
3. Your Hinds brand Custard Powder" product is misbranded under section 403(k) of the Act because it contains artificial coloring and fails to bear labeling stating that fact. FD&C Yellow No. 5 and FD&C Yellow No. 6 are not declared by their listed names or appropriate abbreviations as required under 21 CFR 101.22(k)(l).
4. Your Hinds brand Custard Powder, aah! Bisto Original products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)) in that the nutrition information (e.g. Nutrition Facts Panel) is not in a correct format, as required by 21 CFR 101.9. For example:
• The Hinds brand Custard Powder product label fails to declare a serving size based on the reference amount customarily consumed (RACC) [21 CFR 101.12(b), Table 2] and in a common household measure [21 CFR 101.9(b)(5)], the label fails to list the Trans Fat values [21 CFR 101.9(c)(s)(ii)] and the Nutrition Facts panel is not in the appropriate format for US distribution. The RACC for custard is Y2 cup [21 CFR 101.12 (b), Table 2]. The serving size must be based on the amount of mix that would make the RACC.
• The aah! Bisto Original and Pakco brand Chilli Bite Mix products fail to list a Nutrition Facts panel as required by 21 CFR 101.9 and your firm has not submitted an exemption from such label requirement.
• The Hot Atchar product label fails to declare a serving size based on the reference amount customarily consumed (RACC) [21 CFR 101.12(b), Table 2] and in a common household measure [21 CFR 101.9(b)(5)] and the Nutrition Facts panel is not in the appropriate format for US distribution. lf this product is pickled vegetables, the correct Reference Amount Customarily Consumed is 30 grams per 21 CFR 101.12(b). Table 2. Your “Typical Nutritional Information” panel reflects a serving of 25 grams. If this product is pickled vegetables, all of the nutritional information will need to be adjusted to reflect the correct serving size, in the common household measure, using the rules laid out in 21 CFR 101.9(b)(5)(i)-(iii): cup, tablespoon, teaspoon shall be used when possible. Piece, slice, tray, jar, and fraction shall be used when cup, tablespoon or teaspoon is not applicable. Finally, when none of the above is applicable, ounces with an appropriate visual unit of measure such as a dimension of a piece such as “1 oz (28 g/about 1/2 pickle) may be used.
5. Your Pakco brand Hot Atchar and Pakco brand Chilli Bite Mix products are misbranded within the meaning of section 403(t) of the Act (21 U.S.C. §343(t)] because the label contains information in multiple languages (for example French, Portuguese, Afrikaans. Dutch and Arabic); therefore, all required information must be in both languages (i.e ., the English language as well as all forei gn languages). For example, the statement of identity and ingredient listing must be declared in both all foreign languages and English as required by 21 CFR 101.15(c)(2).
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported products under Section 801 (a) of the Act (21 U.S.C. § 381 (a)], including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the acidified food regulations (21 CFR 108 and 114) is Import Alert #99-37, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods without Filed Scheduled Processes while an Import Alerts that conveys information specific to foreign firms that are not in compliance with the basic labeling requirements is 99-39. You may view these alerts at: http: //www.acccssdata.fda.govcms_ia/ialist.html
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the Acidified regulations (21 CFR 108 and 114), the current Good Manufacturing Practices regulation (21 CFR 110) and the labeling regulations (21 CFR 101). You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. You should take prompt action to correct these violations.
We also have the following comments on your product labeling:
• Your Hinds brand Custard Powder, aah! Bisto Original, Pakco brand Hot Atchar products fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count on the principal display panel as required by 21 CFR 101.105. The net quantity of contents is located on the back or a side panel and is not identified as being the net quantity of content statement.
• Your aah! Bisto Original product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label on the information panel immediately contiguous and to the right of the principal display panel, as required under 21 CFR 101.2.
• On your Pakco brand Hot Atchar, the use of EU numbers to declare ingredients in the ingredient statement is not considered part of the common or usual name in the U.S. and is considered intervening material under 21 CFR 101.2(e).
• On your Hinds brand Custard Powder, the use of non-certified colors when they are required to be certified causes the product to be adulterated, as noted above. Use of the term "Colourants" is not provided for in 21 CFR 101.22. The specific artificial color used in a food shall be identified on the labeling when so required by regulation in part 74 of this chapter to assure safe conditions of use for the color additive, 21 CFR 101.22(c). FD&C Yellow 5 and FD&C Yellow 6 are required to be individually labeled in part 7 4 thus causing your product to be misbranded, as noted above.
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 noncompliance 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- 3l(a)(2)(B)]. For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign 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 reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
We request that you respond to this office in writing, within 15 working days of receipt of this letter. Your response should include, in English the specific steps you have taken to correct the violations. If you cannot complete all of the corrections within 15 working days, your response should state the reason for the delay and the time within which corrections will be completed.
You should direct your written reply to: Tyra Wisecup, Compliance Officer, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740. If you have any questions regarding this letter you may contact Ms. Wisecup via email at firstname.lastname@example.org.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition
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