WARNING LETTER
Tiao Peng Trading, Inc.
MARCS-CMS 603865 —
May 19, 2020
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Danai Kietikul
Recipient Title
Owner
Tiao Peng Trading, Inc.
31760 Hayman St.
Hayward
,
CA
94544
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
May 19, 2020
Re: CMS #603865
Dear Mr. Danai Kietikul:
On January 14‐17, 2020, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at Tiao Peng Trading, Inc. located at 31760 Hayman St., Hayward, CA 94544. We also conducted an inspection on September 12, 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 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 canned black beans, canned red beans, and canned fruit imported from
(b)(4)
, located in
(b)(4)
; fish snack foods imported from
(b)(4)
, located in
(b)(4)
; and custard cake imported from
(b)(4)
, located in
(b)(4)
. You did not have FSVPs for these products. Additionally, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the documents you presented as your FSVPs for your pickled mustard imported from
(b)(4)
, located in
(b)(4)
; curry gravy, imported from
(b)(4)
, located in
(b)(4)
; and tom yum soup paste imported from
(b)(4)
, located in
(b)(4)
. 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 inspection on September 12, 2017 and the follow‐up inspection on January 14 ‐17, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response dated January 27, 2020, where you provided a one‐page letter stating that you are in the process of gathering data and documents to develop FSVP, document to verify that the food was produced according to the low‐acid canned foods regulations, procedures approving foreign suppliers based on evaluation, and procedures verifying foreign suppliers’ activities. However, we are unable to evaluate the adequacy of your corrective actions because you did not include supporting documentation, such as examples of implemented procedures.
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 each of the following foods:
a. Canned black beans, canned red beans, and canned fruit imported from
(b)(4)
, located in
(b)(4)
.
b. Fish snack foods imported from
(b)(4)
, located in
(b)(4)
.
c. Custard cake imported from
(b)(4)
, located in
(b)(4)
.
2. For thermally processed low‐acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards that are controlled by following 21 CFR part 113, you must verify and document that the food was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1). You did not verify and document that your curry gravy, a low‐acid canned food, was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1).
3. You must approve your foreign suppliers on the basis of 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). You did not document your approval of your foreign suppliers of curry gravy and tom yum soup paste imported from
(b)(4)
, as required by 21 CFR 1.505(b).
4. You did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved 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, and document your use of these procedures, as required by 1.506(a)(1).
5. You did not establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the foods you import, as required by 21 CFR 1.506(b).
6. You did not conduct and document (or obtain documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each foreign supplier before importing the food and periodically thereafter, as required by 21 CFR 1.506(e). For example, you did not conduct and document (or obtain documentation of) one or more of such supplier verification activities for your foreign supplier
(b)(4)
before importing pickled mustard and periodically thereafter, for your foreign supplier
(b)(4)
. before importing tom yum soup paste and periodically thereafter, or for your foreign supplier
(b)(4)
. before importing curry gravy and periodically thereafter.
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 these violations, 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 black beans, canned red beans, and canned fruit imported from
(b)(4)
; fish snack foods imported from
(b)(4)
; custard cake imported from
(b)(4)
; pickled mustard imported from
(b)(4)
; curry gravy, imported from
(b)(4)
; and tom yum soup paste imported from
(b)(4)
. We may place the foods from the identified foreign suppliers 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 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: Debbie Giang, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Compliance Officer Giang via phone at (562) 256‐9235 or via email at debbie.giang@fda.hhs.gov. Please reference CMS #603865 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/
Dan R. Solis
Program Division Director
Division of West Coast Imports
Content current as of:
07/21/2020
Regulated Product(s)
Food & Beverages