WARNING LETTER
Handylee USA Corp.
MARCS-CMS 609844 —
October 22, 2020
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Benjamin Lee/Mr. Simon Lee
Recipient Title
Owners
Handylee USA Corp.
5530 58th St
Maspeth
,
NY
11378
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
CMS # 609844
October 22, 2020
Dear Mr. Benjamin Lee & Mr. Simon Lee:
From June 18 through July 7, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection at Handylee USA Corp. located at 5530 58th St. Maspeth, NY 11378. We also conducted an initial FSVP inspection on August 7, 2017. 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 Foreign Supplier Verification Program (FSVP) implementing 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-supplierverification-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 the food products you import including, but not limited to, canned corn imported from your foreign supplier
(b)(4)
; canned mushrooms imported from your foreign supplier
(b)(4)
; and canned bamboo imported from your foreign supplier
(b)(4)
. Your firm did not have FSVPs for these products, or any of the other products that you import. 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 August 7, 2017, and the follow-up inspection on July 7, 2020, our investigator provided you with Form FDA 483a, FSVP Observations.
To this date, we have not received your response to Form FDA 483a, which was issued on July 7, 2020.
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:
• Canned corn imported from
(b)(4)
• Canned mushrooms imported from
(b)(4)
• Canned bamboo imported from
(b)(4)
In addition, for thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods) and with respect to the microbiological hazards associated with these food products, you must verify and document that they were produced in accordance with 21 CFR part 113. Specifically, you did not verify and document that the food products listed above were produced in accordance with 21 CFR part 113 (regarding thermally processed low-acid foods packaged in hermetically sealed containers), as required by 21 CFR 1.502(b)(1).
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 food products you import. We may place the foods you import 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.
In addition to the above violations, we also have the following comments:
In order to comply with the FSVP regulation, you must also conduct a hazard analysis for the products you import in accordance with 21 CFR 1.504. A hazard analysis must identify known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control (21 CFR 1.504(a)). The analysis of the known or reasonably foreseeable hazards in each food must include biological hazards, chemical hazards (including pesticide residues), and physical hazards (21 CFR 1.504(b)(1)). We note that straw mushrooms from
(b)(4)
and
(b)(4)
are currently subject to DWPE as they appear to be adulterated and contain a chemical pesticide that is unsafe with the meaning of section 408(a). You import straw mushrooms from
(b)(4)
and you import golden and oyster mushrooms from
(b)(4)
. Applicable FDA food safety regulations and information relevant to your foreign supplier’s compliance with those regulations, including but not limited to whether or not your foreign supplier is subject to an import alert is an important aspect of evaluating your foreign supplier’s performance (21 CFR 1.505). Furthermore, understanding the known or reasonably foreseeable hazards, such as pesticides, in the foods you import should be considered when determining the appropriate foreign supplier verification activities (21 CFR 1.506).
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 revised 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 # 609844 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:
11/03/2020
Regulated Product(s)
Food & Beverages