WARNING LETTER
Pacific Exchange Distributors LLC
MARCS-CMS 683014 —
September 12, 2024
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Atsushi (Chris) Watanabe
Recipient Title
Owner/President
Pacific Exchange Distributors LLC
1525 W Wardlow Rd
Long Beach
,
CA
90810-2158
United States
Issuing Office:
Division of West Coast Imports
United States
Secondary Issuing Offices
United States
September 12, 2024
WARNING LETTER
Re: CMS # 683014
Dear Mr. Atushi (Chris) Watanabe:
On March 27, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Pacific Exchange Distributors LLC., located at 1525 W Wardlow Rd, Long Beach, CA 90810-2158. We also conducted an inspection from August 16, 2018 to August 17, 2018; August 5, 2020 to August 13, 2020; and June 7, 2023. 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-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 foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.
We acknowledge receipt of your response on April 9, 2024. You stated you have obtained FSVP information, in English from your foreign supplier,
(b)(4)
, for Seasoned Radish Strips. You also provided FSVP information for your foreign suppliers,
(b)(4)
, for Seasoned Plum, and
(b)(4)
, for Seasoned Mustard Greens, which were prepared by a food specialist
(b)(4)
because of difficulties dealing directly with these foreign suppliers. You did not explain if the food specialist is a qualified individual performing FSVP activities on your behalf. The documents you provided included the following:
HACCP documentation for Seasoned Radish Strips (Dried strips of daikon radish stew) from
(b)(4)
which consists of the following: Cover page, Revision Details, Product Details, HACCP team members, Flow Diagram (Dried strips of daikon radish stew), Hazard Factor List, HACCP Plan.
FSVP documents pertaining to Seasoned Plum (product names:
(b)(4)
and
(b)(4)
) from
(b)(4)
which consists of: Product Description, Flow Diagram, Hazard Analysis, and Process Control.
FSVP documents pertaining to Seasoned Mustard Greens (product name:
(b)(4)
) from
(b)(4)
which consists of: Product Description, Flow Diagram, Hazard Analysis, and Process Control.
Your significant violations of the FSVP regulation are as follows:
1. 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, you did not develop an FSVP for most of the foods you import
except for
the following foods:
Seasoned Radish Strips (Dried strips of daikon radish stew) imported from
(b)(4)
,
Seasoned Plum imported from
(b)(4)
Seasoned Mustard Greens imported from
(b)(4)
2. You did not conduct a written hazard analysis for each type of food you import to determine whether there are any hazards requiring a control, as required by 21 CFR 1.504(a). Although you may meet your requirement to determine whether there are any hazards requiring a control by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, you must document your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). Specifically, in your response dated April 9, 2024, you provided FSVP information, including hazard analyses for your Seasoned Radish Strips (Dried strips of daikon radish stew) obtained from your foreign supplier, and for your Seasoned Plum and Seasoned Mustard Greens obtained from a food specialist
(b)(4)
. However, you did not document your review and assessment of these hazard analyses conducted by another entity. In addition, you did not document if these hazard analyses were conducted by qualified individual, as required by 21 CFR 1.504(d).
3. You did not approve your foreign suppliers based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505(a), and document your approval, as required by 21 CFR 1.505(b). During our inspection, you did not provide our FDA investigator documentation of an evaluation of the foreign supplier’s performance and the risk posed by the food for the Seasoned Radish Strips, Seasoned Plum and Seasoned Mustard Greens products you import from your foreign suppliers,
(b)(4)
, and
(b)(4)
. In addition, in your response dated April 9, 2024, you did not include any documentation of your approval of your foreign suppliers based on an evaluation of your foreign suppliers’ performance and the risk posed by these foods.
4. You did not perform foreign supplier verification and related activities in accordance with 21 CFR 1.506 for the foods your import. Specifically, you did not establish and follow written procedures for ensuring that appropriate foreign supplier verification activities are conducted in accordance with 21 CFR 1.506(b), and you did not determine and document your determination of the appropriate foreign supplier verification activity or activities, or the frequency with which the activity or activities must be conducted, before importing Seasoned Radish Strips, Seasoned Plum and Seasoned Mustard Greens products from your foreign suppliers, as required by 21 CFR 1.506(d). During the inspection, you were unable to provide documentation of your verification activities for Seasoned Radish Strips imported from
(b)(4)
, Seasoned Plum (
(b)(4)
and
(b)(4)
) from
(b)(4)
, and Seasoned Mustard Greens from
(b)(4)
. In addition, in your response dated April 9, 2024, you did not provide documentation that you have established written procedures for ensuring that appropriate foreign supplier verification activities are conducted before importing foods from these foreign suppliers.
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.
Additionally, we offer the following comments:
Pesticides are a known or reasonably foreseeable food-related chemical hazard for fruits and vegetables. However, your hazard analyses for your Seasoned Radish (Dried strips of daikon radish stew), Seasoned Plum (
(b)(4)
and
(b)(4)
), and Seasoned Mustard Greens do not list pesticides as a potential chemical hazard at the receiving step and evaluate whether it is a hazard requiring a preventive control. Your FSVP documents pertaining to Seasoned Mustard Greens describe product packaged in glass jars, however your hazard analysis did not evaluate whether glass is a hazard requiring a preventive control. The Seasoned Mustard Greens finished product pH is
(b)(4)
±
(b)(4)
with salt content of
(b)(4)
±
(b)(4)
% and would be considered a low acid canned food (LACF), except it is labeled “Keep Refrigerated”. The heat treatment described in your process flow diagram for the Seasoned Mustard Greens product, i.e.,
(b)(4)
～
(b)(4)
℃ /
(b)(4)
min or more, is not sufficient to destroy
Clostridium botulinum
spores in an LACF and therefore refrigerated temperature controls after the heat treatment (e.g., during warehouse storage and transportation) are needed to ensure the safety of your product. Simply labeling “keep refrigerated” is insufficient and the hazard analysis submitted did not include appropriate temperature controls.
We also note that your Seasoned Plum products (product names:
(b)(4)
and
(b)(4)
) appear to have a finished pH of <
(b)(4)
(
(b)(4)
was used to lower the pH) and are labeled as “keep refrigerated”. Regulations under 21 CFR part 114 for acidified foods would apply to these products unless the products are stored, distributed, retailed, and labeled as keep refrigerated. However, simply labeling the products as refrigerated is insufficient; your firm must demonstrate that the products are maintained under refrigerated conditions during the entire shelf life of the product. If you cannot provide such records, the products would be considered acidified and would be subject to 21 CFR 114.
In addition, FDA has determined that
(b)(3)(A)
. Our records indicate that,
(b)(3)(A)
.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
(b)(3)(A)
This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, 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 you import for which you appear to be in violation of section 805. We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods. 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 (21 U.S.C. 331(zz)).
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 any 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 working 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: Lin Liu, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831, with a copy via electronic email to WCID@FDA.HHS.GOV. If you have any questions regarding this letter, you may contact Mr. Lin Liu via email at lin.liu@fda.hhs.gov. Please reference CMS #683014 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports
Content current as of:
10/01/2024
Regulated Product(s)
Food & Beverages