WARNING LETTER
The Cookie Boys MARCS-CMS 510024 —
- Recipient:
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Recipient NameMr. Jeffrey M. Heilman
- The Cookie Boys
1058 Broadway Ave
San Jose, CA 95125
United States
- Issuing Office:
- San Francisco District Office
United States
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1431 Harbor Bay Parkway
Alameda, CA 94502-7070
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WARNING LETTER
March 3, 2017
Mr. Jeffrey M. Heilman, Owner
The Cookie Boys
1058 Broadway Ave
San Jose, CA 95125
Dear Mr. Jeffrey M. Heilman:
The U.S. Food and Drug Administration (FDA) inspected your bakery facility, located at 1058 Broadway Ave., San Jose, CA, between September 19-20 and 22, 2016. During the inspection, the FDA investigator documented serious violations of the current Good Manufacturing Practice (cGMP) Regulations, Part 110 [Title 21 CFR Part 110]. These violations cause the cookie products manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. §342(a)(4)] in that they were 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. You may find the Act and these regulations through links in FDA’s home page at www.fda.gov.
At the conclusion of the inspection, the Investigators issued your firm an FDA Form 483, Inspectional Observations, dated September 22, 2016. As of this time, your firm has not submitted a written response to the observations documented on the FDA Form 483.
Your significant violations are as follows:
1. Failure to ensure that all persons working in direct contact with food, food-contact surfaces and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food as required 21 CFR 110.10(b)(3). Specifically, an employee was observed touching non-food contact surfaces, such as the oven door handle, cleaning bucket, and a door handle without washing or sanitizing hands and proceeded to handle cookie dough with bare hands. When washing hands, the same employee was observed cracking eggs, then touching the faucet to turn on the water to wash hands, touching the faucet to turn off the water with washed hands and proceeded to handle cookie dough with bare hands, which can contribute to cross contamination following the wash.
Washing hands thoroughly is necessary to protect against contamination with undesirable microorganisms. Hand washing should take place in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated.
Your firm stated at the close of the inspection that a new hand sanitizing procedure would be implemented within two weeks of the inspection, for example using a paper towel to turn off the faucet. Your firm also mentioned placing a sign in the bathroom which reminds employees to wash their hands, purchasing hair nets and gloves and to require employees begin wearing these while manufacturing product. Additionally, your firm mentioned you will place several rolls of paper towels in the bathroom. Hand washing/sanitizing procedures will be verified during the next inspection.
2. Failure to confine the following to areas other than where food may be exposed or where equipment or utensils are wash: eating food, chewing gum, drinking beverages, or using tobacco as required by 21 CFR 110.10(b)(8). Specifically, an employee was observed drinking a beverage while handling cookie dough and ready-to-eat cookies during production.
3. Failure to ensure that all work-in-process is handled in a manner that protects against contamination as required by 21 CFR 110.80(b)(5). Specifically:
• Iced shortbread cookies were observed sitting on a cooling racks overnight, unprotected and open to the environment, to air dry during non-production hours in an area accessible to non-production personnel.
• Cookie cooling racks were observed to not have been routinely clean and sanitized between manufacturing of various dough products to prevent allergen cross-contact, specifically between shortbread, peanut butter and snickerdoodle cookie dough. On 09/19/2016, peanut butter cookies containing peanuts were cooling on a rack approximately 3/4 inch from shortbread cookies. This issue of your firm’s failure to adequately clean and sanitize cooling racks between use or to hold the products in close proximity with a potential for cross contamination is a concern because these cookie products contain different allergenic substances that will not be declared on the labels of each finished cookie product.
Labeling
1. Your Iced Shortbread Cookie product is adulterated within the meaning of section 402(c) of the Act [21 U.S.C. 342(c)] because the product bears or contain a color additive which is unsafe within the meaning of section 721(a) of the Act [21 USC 379e(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive listing regulation. Specifically, the listing regulation for FD&C Yellow No.5 requires that the color additive be listed by that name in the ingredient list on the labels of foods for human use [21 CFR
74.705(d)(2)]. Your Iced Shortbread Cookie product is manufactured with Brilliant Blue FCF and Tartrazine ingredient, which contains FD&C Blue#1 and FD&C Yellow No.5; however, the labels for these products fail to declare the presence of FD&C Blue #1 and FD&C Yellow #5 in the ingredient statement.
2. Your Iced Shortbread Cookie product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the product contains color additives but does not declare it on the label, which is unsafe within the meaning of section 721(a) of the Act. In accordance with 21 CFR 101.22(k), the label of a food to which any coloring has been added shall declare the coloring in the statement of ingredients. Your Iced Shortbread Cookie product is manufactured with Brilliant Blue FCF (certifiable as FD&C Blue #1) and Tartrazine (certifiable as FD&C Yellow #5); however, the products label fails to identify the presence of these color additives. Under 21 CFR 101.22(k)(1), certified colors must be declared by the name of the color additive listed in the applicable regulation in part 74 or part 82 of this chapter. The common or usual name may be abbreviated to omit the "FD&C" prefix and the term "No." (e.g., Yellow 5).
3. Your Iced Shortbread Cookies is misbranded within the meaning of Section 403(i)(2) [21 U.S.C. § 343(i)(2)] of the Act because the ingredient declaration “food coloring (may vary)” is not in accordance with 21 CFR 101.4(a)(1) and 101.22(k).
4. Your Shortbread Cookies, Oatmeal Butterscotch Cookies, and Chocolate Chip Cookies w/Walnuts products are misbranded within the meaning of Section 403(e)(1) [21 U.S.C. § 343(e)(1)] of the Act because they fail to declare a label containing the name of the manufacturer, packer or distributor as required by 21 CFR 101.5.
5. Your Shortbread Cookies, Oatmeal Butterscotch Cookies, and Chocolate Chip Cookies w/Walnuts products are misbranded within the meaning of Section 403(e)(2) [21 U.S.C. 343(e)(2)] in that the label fails to declare the net quantity of contents as required by 21 CFR 101.7.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, and the Current Good Manufacturing Practice regulation (21 CFR Part 110).
In addition, we offer the following comments regarding your products:
• Your Shortbread Cookies, Oatmeal Butterscotch Cookies, and Chocolate Chip Cookies w/Walnuts product labels have a “contains” statements, however, they are missing major allergens. Specifically, the allergen statements that are being used on your labels are not consistent. The labels declare the allergens in the ingredient statement, however, all of the allergens are not being declared in the “Contains” statement.
o Under FALCPA, the "Contains" statement must include the names of the food sources of all major food allergens used as ingredients in the packaged food. For example:
- Your shortbread cookies labels “contains” statement does not declare milk
- Your Oatmeal Butterscotch Cookies labels “contains” statement does not declare milk
- Your Chocolate Chip Cookies w/Walnuts labels “contains” statement does not declare milk and Tree nuts (walnuts).
• Oatmeal Butterscotch Cookies
o The ingredient list on the oatmeal butterscotch cookie label is not in accordance with 21 CFR 101.4. For example,
- We question whether the list is declared in descending order of predominance by weight because butter, sugar and eggs are listed after soy lecithin, salt, and colors.
- The common or usual name for niacin does not include “(A B Vitamin)”.
- Flavors must be declared in accordance with 21 CFR 101.22(h). The combined declaration “natural and artificial flavors (including barley protein)” is not permitted. In addition, we question the purpose of the parenthetical declaration.
o Colors must be declared in accordance with 21 CFR 101.22(k). The combined declaration “artificial colors (yellow 5 lake, yellow 6 lake, blue 2 lake)” is not permitted.
o Under 21 CFR 101.5(d), the city must be included in the declaration of the place of business. “SJ” is not the name of a city in California.
o Under 21 CFR 101.15(a)(6), a word, statement, or other information required by or under authority of the act to appear on the label may lack prominence and conspicuousness required by section 403(f) of the act by reason of insufficient background contrast. We note that the place of business is printed in a light color on a white background that lacks contrast.
• Chocolate Chip Cookies w/Walnuts
o Under 21 CFR 101.5(d), the city must be included in the declaration of the place of business. “SJ” is not the name of a city in California.
o We question if the ingredient list is in descending order of predominance by weight. [21 CFR 101.4(a)(1)]
o The common or usual name for niacin does not include “(A B Vitamin)”. [21 CFR 101.4(a)(1)]
• Iced Shortbread Cookies
o Under 21 CFR 101.5(d), the city must be included in the declaration of the place of business. “SJ” is not the name of a city in California.
o Based on the EIR (page 5), the icing is made with water which is not declared in the ingredient list. [21 CFR 101.4(a)(1)]
o The common or usual name for niacin does not include “(A B Vitamin)”. [21 CFR 101.4(a)(1)]
o The webpage bears an allergen advisory statement. We note that such statements must be truthful and not misleading and are not to be used in lieu of good manufacturing practices.
o The webpage includes ingredients list for the oatmeal butterscotch cookies and chocolate chip cookies w/ walnuts. Therefore, the comments for the ingredient lists on the labels of these products would also apply to the lists on the webpage.
• In addition, your webpage at https://www.thecookieboys.com/pages/about-us states, “The Cookie Boys have become…FDA approved!” Since FDA does not approve food manufacturers, this is a false statement.
You should take prompt action to correct these violations and to establish procedures whereby such violations do no recur. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to seizure and injunction.
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 a noncompliance materially related to food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expense incurred in connection with FDA’s arranging, conducting and evaluating the results of the re-inspection assessing and collecting the re-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 cost.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things that you are doing to correct these violations. You may wish to include in your response documentation such as labels, and photographs of corrections your firm has taken or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen (15) days, please provide the reason for the delay and provide a timeline for correcting these violations.
Please send your reply to the Food and Drug Administration, Attention:
Lawton W. Lum,
Director of Compliance
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference Case number 510024
If you have questions regarding this letter, please contact Tammy Hancock at 510-337-6737.
Sincerely Yours,
/S/
Darla R. Bracy
Acting District Director