WARNING LETTER
Aspen Sales Group
MARCS-CMS 609365 —
October 07, 2020
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Laurie Bogle
Recipient Title
CFO
Aspen Sales Group
350 Main St., Suite 6A
Bedminster
,
NJ
07921-2603
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER CMS # 609365
Dear Ms. Bogle:
From May 29 through June 10, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Aspen Sales Group, located at 350 Main St., Suite 6A, Bedminster, NJ 07921-2603. We also conducted an on-site inspection on March 29, 2018. 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 food products you import, including but not limited to Refined Sugar imported from
(b)(4)
, located in
(b)(4)
; and Fries 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 FSVP for your Frozen French Fries 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 FSVP inspection on March 29, 2018 and the follow-up inspection on June 10, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We have not received your response to either of the Form FDA 483a.
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 foods you import, including but not limited to:
o Fries imported from your foreign supplier,
(b)(4)
, located in
(b)(4)
;
and
o Refined Sugar imported from your foreign supplier,
(b)(4)
, located in
(b)(4)
.
2. 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 21 CFR 1.506(a)(1).
3. 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).
4. 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. Although you may meet this requirement 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)). While you have obtained the hazard analysis from your foreign supplier for your Frozen French Fries imported from your foreign supplier
(b)(4)
and documented that you reviewed it, there was no documentation that the hazard analysis was conducted by a qualified individual, as required under 21 CFR 1.504(d).
5. You did not meet the requirement to, before importing a food from a foreign supplier, determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food you obtain from the foreign supplier is produced in accordance with 21 CFR 1.506(c), as required by 21 CFR 1.506(d). Specifically, for your Frozen French Fries imported from your foreign supplier
(b)(4)
, your “Vendor Approval” document states that you “monitor[]
(b)(4)
continued compliance via third party audits,” but it does not state the frequency with which these audits must be conducted, as required by 21 CFR 1.506(d).
6. You did not meet the requirement to 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). Specifically, for your Frozen French Fries imported from your foreign supplier
(b)(4)
, your “Vendor Approval” document states that you “monitor[]
(b)(4)
continued compliance via third party audits,” and you provided copies of third-party audit certificates dated 2016 and 2017. While you may rely on supplier verification activities conducted in accordance with 21 CFR 1.506(e)(1) by another entity, you must promptly review and assess the results of the verification activities conducted by another entity and document your review and assessment (21 CFR 1.506(e)(3)). In addition, you must retain documentation of each onsite audit, including the audit procedures, the dates the audit was conducted, the conclusions of the audit, any corrective actions taken in response to significant deficiencies identified during the audit, and documentation that the audit was conducted by a qualified auditor (21 CFR 1.506(e)(1)(i)(D)). For food that is subject to one or more FDA food safety regulations, an onsite audit of the foreign supplier must consider such regulations and include a review of the supplier’s written food safety plan, if any, and its implementation, for the hazard being controlled (21 CFR 1.506(e)(1)(i)(B)).
The third-party audit certificates you provided, dated 2016 and 2017, do not include audit procedures; they also do not indicate that they assessed compliance with FDA food safety regulations, reviewed the supplier’s written food safety plan, or were conducted by a qualified auditor. Further, you did not provide any documentation showing that you or another entity are conducting supplier verification activities periodically after importing the food.
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 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:
You provided FDA with a copy of your foreign supplier
(b)(4)
hazard analysis for Frozen French Fries. We note that 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, and physical hazards (21 CFR 1.504(b)(1)). A hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury (21 CFR 1.500). Your foreign supplier’s hazard analysis lists “physical”, “chemical”, and “biological” hazards but does not list specific hazards (e.g., specific microorganisms or pathogens) for each type of hazard. In order to adequately determine which hazards require a control, the hazard analysis should identify the specific relevant hazard (e.g., the relevant microorganisms or pathogens).
For your Frozen French Fries imported from your foreign supplier
(b)(4)
, located in
(b)(4)
, you provided your “Vendor Approval” form dated March 29, 2018, which documents that
(b)(4)
. is approved as a foreign supplier. We note that in approving your foreign suppliers and determining the appropriate supplier verification activities that must be conducted for a foreign supplier of a type of food you import, you must consider, among other things, your foreign supplier’s performance, including: (A) the foreign supplier's procedures, processes, and practices related to the safety of the food; (B) applicable FDA food safety regulations and information relevant to the foreign supplier’s compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety; and (C) the foreign supplier's food safety history, including available information about results from testing foods for hazards, audit results relating to the safety of the food, and responsiveness of the foreign supplier in correcting problems (21 CFR 1.505(a)(1)(iii)). Your “Vendor Approval” form and the other documents you provided do not indicate that you have considered all relevant aspects of the foreign supplier’s performance in accordance with 21 CFR 1.505(a)(1)(iii).
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: Teresa T. Cain, FDA Compliance Officer, Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) teresa.cain@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Cain via email at teresa.cain@fda.hhs.gov. Please reference CMS # 609365 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:
10/20/2020
Regulated Product(s)
Food & Beverages