WARNING LETTER
Foodworks International LLC
MARCS-CMS 590233 —
October 16, 2019
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Panithan (Dan) Narmsthien
Recipient Title
President
Foodworks International LLC
3670 131st Ave N
Clearwater
,
FL
33762-4262
United States
Issuing Office:
Division of Southeast Imports
United States
October 16, 2019
WARNING LETTER
Re: CMS # 590233
Dear Mr. Panithan (Dan) Narmsthien:
On July 23rd, 2019, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at 3670 131st Ave N. Clearwater, FL, 33762-4262. This inspection was 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/GuidanceRegulation/FSMA/ucm361902.htm
During our July 23, 2019 inspection, we found that you are not in compliance with the requirements of 21 CFR 21 CFR part 1 subpart L for products that you import from your foreign suppliers. 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, and the follow-up inspection on July 23rd, 2019, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We have not received your response to the Form FDA 483a.
Our finding during the July 23, 2019 inspection was consistent with our finding during a previous inspection of your firm. During a March 5, 2018 inspection, we also found that you were not in compliance with section 805 of the FD&C Act.
Your significant violations of the FSVP regulation are as follows: You did not develop an FSVP as required by the FSVP rule (see 21 CFR 1.502(a)). Specifically, your firm did not develop an FSVP for Canned Jackfruit in Syrup and Canned Palm Seeds in Syrup manufactured by
(b)(4)
, and Sweet Chili Sauce in Glass Bottles manufactured by
(b)(4)
.
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 Canned Jackfruit in Syrup and Canned Palm Seeds in Syrup manufactured by
(b)(4)
, and Sweet Chili Sauce in Glass Bottles manufactured by
(b)(4)
. We may place these foods on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert # 99-41at
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 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 your products 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: CDR Lundy Patrick, Compliance Officer, Division of South East Imports, 15100 NW 67th Ave. Suite 400, Miami, FL 33014. If you have any questions regarding this letter, you may contact CDR Patrick via email at lundy.patrick@fda.hhs.gov. Please reference CMS # 590233 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/
Ruth Dixon
Program Division Director
Division of Southeast Imports
Content current as of:
10/22/2019
Regulated Product(s)
Food & Beverages