WARNING LETTER
David Rosen Bakery Supplies Inc. DBA David Rosen Company
MARCS-CMS 605118 —
April 01, 2020
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Jeremy Rosen
Recipient Title
President
David Rosen Bakery Supplies Inc. DBA David Rosen Company
59-21 Queens Midtown Expressway
Maspeth
,
NY
11378-1220
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
CMS # 605118
April 1, 2020
Dear Mr. Rosen:
On February 5, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) follow-up inspection at David Rosen Bakery Supplies Inc. 5921 Queens Midtown Expressway; Maspeth, NY 11378-1220. We also conducted an initial inspection on July 26, 2018. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals
.
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your FSVPs for the following products manufactured by Grupo La Florida Mexico S.A. de C.V. (Tlalnepantla de Baz, Tlalnepantla, Mexico):
• Strawberry Filling Diamante
• Pineapple Filling Diamante
• Multicolor Sprinkles Diamante
Your firm did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection on July 26, 2018, and the follow-up inspection on February 5, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We have not received your response to either Form FDA 483a.
Your significant violations of the FSVP regulation are as follows:
You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, your firm did not develop an FSVP for each of the following foods manufactured by Grupo La Florida Mexico S.A. de C.V. (Tlalnepantla de Baz, Tlalnepantla, Mexico):
• Strawberry Filling Diamante,
• Pineapple Filling Diamante, and
• Multicolor Sprinkles Diamante
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the Strawberry Filling Diamante, Pineapple Filling Diamante, and Multicolor Sprinkles Diamante foods manufactured by Grupo La Florida Mexico S.A. de C.V. (Tlalnepantla de Baz, Tlalnepantla, Mexico). We may place the foods from the identified foreign supplier on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert # 99-41 at
http://www.accessdata.fda.gov/cms_ia/ialist.html
. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation). If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: David A Trent-Carlson, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) david.trent-carlson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Trent-Carlson via email at david.trent-carlson@fda.hhs.gov. Please reference CMS # 605118 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dawne Hines
Program Division Director
Division of Northeast Imports
Content current as of:
04/14/2020
Regulated Product(s)
Food & Beverages