FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/imad-international-llc-613268-03292021
IMAD International, LLC
MARCS-CMS 613268 — MARCH 29, 2021
Recipient:
Ahmed Ladejobi
Owner
IMAD International, LLC
1565 Theriot Ave, Apt 6G
Bronx, NY 10460
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
CMS # 613268
March 29, 2021
Dear Mr. Ladejobi:
On January 14, 2021, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection for IMAD International, LLC located at 1565 Theriot Ave, Apt 6G, Bronx, New York 10460. We also conducted an inspection on April 18, 2019. 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 our most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your honey beans and melon seeds imported from (b)(4) located in (b)(4) and your plantain chips imported (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 April 18, 2019 and the follow-up inspection on January 14, 2021, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
At the close of the most recent inspection, you stated to the investigator that you are currently working on the FSVP plan with a third-party consultant and it should be completed within the next few weeks. We have not received your response to either Form FDA 483a.
Your significant violations of the FSVP regulation are as follows:
1. For the plantain chips imported from your foreign supplier (b)(4), 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). Because (b)(4) appears to be on the CFIA list of firms in good standing, you may be eligible to follow the modified requirements in 21 CFR 1.513 for that product.
2. For the melon seeds and honey beans imported (b)(4), you did not meet your requirements to conduct a hazard analysis in accordance with 21 CFR 1.504(a). During the inspection, you provided a copy (b)(4) Food Safety Analysis – Hazard Analysis. You may meet your requirement to conduct a hazard analysis, as required by 21 CFR 1.504(a), by reviewing and assessing your supplier’s hazard analysis and documenting your review and assessment of your supplier’s hazard analysis as required by 21 CFR 1.504(d).
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 supplier of melon seeds and honey beans imported (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 21 CFR 1.506(a)(1).
5. You did not establish and follow written adequate procedures ensuring that foreign supplier verification activities are conducted with respect to the food you import as required by 21 CFR 1.506(b).
6. You did not meet the requirements 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)(1). Specifically, you did not conduct and document (or obtain documentation) of one or more supplier verification activities for your foreign supplier (b)(4) before importing melon seeds and honey beans periodically thereafter.
The above matters 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. Failure to adequately address this matter may result in 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 products you import that appear to be in violation of section 805. 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.
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: Slater Bartlett, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) slater.bartlett@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Bartlett via email at slater.bartlett@fda.hhs.gov. Please reference CMS # 613268 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
The above matters 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. Failure to adequately address this matter may result in 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 products you import that appear to be in violation of section 805. 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.
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: Slater Bartlett, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) slater.bartlett@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Bartlett via email at slater.bartlett@fda.hhs.gov. Please reference CMS # 613268 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
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