- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Pardeep K. Salwan
- Apna Foods Imports Co.
360 S. Lombard Rd.
Addison, IL 60101-3024
- Issuing Office:
- Division of Northern Border Imports
Re: CMS # 622620
Dear Mr. Salwan:
On November 15 and 30, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Apna Foods Imports Co. located at 360 S. Lombard Rd., Addison, IL 60101-3024. We also conducted inspections on August 6, 2018 and August 11, 2020. 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 were not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import: black gram split and semolina imported from (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 our investigator provided you with a Form FDA 483a FSVP Observations. We have not received your response to the Form FDA 483a issued on November 30, 2021.
Your significant violations of the FSVP regulation are as follows:
1. You must conduct a 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). During the inspection, you stated that your foreign supplier wrote your FSVP. You provided hazard analyses obtained from your foreign supplier, (b)(4), for black gram split and semolina. Although you may meet the requirements of 21 CFR 1.504(a) 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)). However, you did not provide FDA documentation that you reviewed and assessed your foreign supplier’s hazard analyses for the black gram split and semolina imported from (b)(4), as required by 21 CFR 1.504(d). The hazard analyses you provided for these foods each stated that for potential biological, chemical, and physical hazards, there were no significant potential food safety hazards, yet also identified preventive measures as critical control points to control biological and physical hazards. Therefore, it is unclear if your foreign supplier’s hazard analyses determined whether there are any hazards requiring a control for these foods.
2. You did not 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). Specifically, for your foreign supplier (b)(4), you did not evaluate your foreign supplier’s performance and risk posed by the food in accordance with 21 CFR 1.505(a) or approve your supplier on the basis of this evaluation and document your approval of the supplier in accordance with 21 CFR 1.505(b).
3. You did not establish and follow written procedures to ensure that you import foods only from approved 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). Specifically, you have not established written procedures for approving foreign suppliers for any of your imported foods.
4. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506 for the products you import. Specifically, you did not document your determination or performance of appropriate supplier verification activities for the black gram split or semolina imported from (b)(4). You did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b) and you did not document your determination of the appropriate supplier verification activity in accordance with 21 CFR 1.506(d), and you did not document (or obtain documentation of) performance of one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for your foreign supplier (b)(4) before importing food and periodically thereafter, as required by 21 CFR 1.506(e).
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.
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 from the identified foreign supplier 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 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, FDA Division of Northern Border Imports, 300 River Place, Suite #5900, Detroit, MI 48207. If you have any questions regarding this letter, you may contact Vanessa Colburn via email at firstname.lastname@example.org. Please reference CMS # 622620 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports
300 River Place, Suite #5900
Detroit, MI 48207