WARNING LETTER
American Distribution and Manufacturing Co., LLC
MARCS-CMS 660340 —
October 12, 2023
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Jon Duclos
Recipient Title
Owner
American Distribution and Manufacturing Co., LLC
7900 97th St S
Cottage Grove
,
MN
55016-4343
United States
Issuing Office:
Division of Northern Border Imports
United States
October 12, 2023
WARNING LETTER
CMS # 660340
Dear Mr. Jon Duclos:
From April 13 through May 12, 2023, the U.S. Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of American Distribution and Manufacturing Co., LLC located at 7900 97th St S, Cottage Grove, MN 55016-4343. 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 implementing FSVP regulation in 21 Code of Federal Regulations (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 on FDA’s home page at www.fda.gov.
Our inspection revealed evidence of significant violations with the requirements of 21 CFR part 1, subpart L, for the dry kibble cat food (poultry flavor) and the dry kibble dog food (lamb/venison flavor) that you import from
(b)(4)
, located in
(b)(4)
, and the
(b)(4)
feed additive (diatomaceous earth feed additive) that you import 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 the inspection, you were issued a Form FDA 483a, FSVP Observations, on May 12, 2023. FDA received your written response dated June 13, 2023, and we address your response below.
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 the following foods:
Dry kibble cat food (poultry flavor) imported from
(b)(4)
, located in
(b)(4)
Dry kibble dog food (lamb/venison flavor) imported from
(b)(4)
, located in
(b)(4)
(b)(4)
feed additive (diatomaceous earth feed additive) imported from
(b)(4)
, located in
(b)(4)
2. You must 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. Specifically, during the inspection you provided the written hazard analysis from your foreign supplier for your
(b)(4)
feed additive (diatomaceous earth feed additive) imported from
(b)(4)
. However, you did not provide FDA with any documentation that you reviewed and assessed your foreign supplier’s hazard analysis, as required by 21 CFR 1.504(d).
In your response dated June 13, 2023, you state that
(b)(4)
and
(b)(4)
have been listing American Distribution & Manufacturing Co, LLC as the Importer of record.” You also state that you were not “aware we were listed on the import documents so therefore didn’t have an FSVP program in place.” You further state that you have “been in contact with both suppliers [
(b)(4)
and
(b)(4)
] in question and are working towards having the supplier listing themselves as the importer, therefore removing the requirement of ADMC implementing and maintaining a Foreign Supplier Verification Program.” The FSVP regulation defines an importer as the U.S. owner or consignee of an article of food that is being offered for import into the United States (See 21 CFR 1.500). The foreign suppliers of your products do not meet the definition of an importer under 21 CFR 1.500. As the owner or consignee of food that is being offered for import into the United States, you are the importer. You stated that you are “researching other options such as hiring an outside contractor to implement and maintain a FSVP on our behalf.” You have not provided any additional details or documentation demonstrating you have taken corrective action.
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 comply with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.
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 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 from the identified foreign suppliers 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 State of an article of food without the importer having 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)).
Additionally, we offer the following comment:
A Qualified Individual must develop your FSVP and must include the following documents under the standard requirements:
a. The written hazard analysis and evaluation, as required by 21 CFR 1.504.
b. Documentation of the evaluation (and reevaluation) of your foreign supplier’s performance and the risk posed by the foods, as required in 21 CFR 1.505(a) and 21 CFR 1.505(c) or 21 CFR1.505(d).
c. Documented approval of your foreign suppliers based on the evaluation, as required in 21 CFR1.505(b).
d. Written procedures to ensure you import foods only from approved foreign suppliers (or, when necessary, appropriate, and on a temporary basis from unapproved foreign suppliers) and documented use of those procedures, as required in 21 CFR 1.506(a).
e. Determination of appropriate foreign supplier verification activities and written procedures for ensuring the verification activities are conducted, as required by 21 CFR 1.506(b) and 21 CFR1.506(d).
f. Documentation of the conducted verification activities, as required by 21 CFR 1.506(e).
g. Documented corrective actions, if applicable, as required by 21 CFR 1.508.
For more information about FDA’s current thinking on the requirements of 21 CFR part 1, subpart L, see:
“Foreign Supplier Verification Programs for Importers of Food for Humans and Animals:Guidance for Industry” https://www.fda.gov/media/118241/download
Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food forAnimals” https://www.fda.gov/media/110477/download
“Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP)Regulation Records Requirements” https://www.fda.gov/media/131229/download
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 FSVPs, records to demonstrate implementation of your FSVPs), 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 corrections within fifteen (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: Vanessa Colburn, Compliance Officer, Division of Northern Border Imports. If you have any questions regarding this letter, you may contact Compliance Officer Colburn via email at Vanessa.Colburn@fda.hhs.gov. Please reference CMS # 660340 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports
Content current as of:
11/14/2023
Regulated Product(s)
Food & Beverages