FDA issued a Warning Letter to Patidar Trade, Inc. of North Brunswick, NJ because they were in violoation fo teh Foreign Supplier Verification Program Regulation (FSVP) which requires companies to conduct a hazard analysis and enact verification procedures for items that are imported. The comany 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, the company did not develop, maintain, and follow an FSVP for any of the imported foods including each of the following food products:
Wheat flour imported from (b)(4)
Rice flour imported from (b)(4)
Phool makhana imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/patidar-trade-inc-619282-01062022
Patidar Trade, Inc.
MARCS-CMS 619282 — JANUARY 06, 2022
Recipient: Rajesh Patel
Owner
Patidar Trade, Inc.
1463 Finnegan Lane
North Brunswick, NJ 08902
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
January 6, 2022
Re: CMS # 619282
Dear Mr. Rajesh Patel:
On August 10 through September 10, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Patidar Trade, Inc. located at 1463 Finnegan Lane, North Brunswick, NJ. We also conducted an inspection on August 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-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 the foods you import. 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 September 10, 2021.
Your significant violations of the FSVP regulation are as follows:
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, maintain, and follow an FSVP for any of the foods you import including each of the following food products:
Wheat flour imported from (b)(4)
Rice flour imported from (b)(4)
Phool makhana imported from (b)(4)
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. 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 for which you appear to be in violation of section 805. We may place the foods you import into the United States 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)).
Additionally, we offer the following comments:
In your response to the issued Form FDA 483a from the previous inspection, you stated your firm meets the definition of very small importer as defined in 21 CFR 1.500, and therefore is subject to the modified FSVP requirements in 21 CFR 1.512. During the most recent inspection, you did not provide documentation that you meet the definition of very small importer in §1.500 with respect to the foods you import. If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer as required by 21 CFR 1.512(b)(1)(i). If this section applies and you choose to comply with the requirements in paragraph (b) of this section, you also are required to comply with the requirements in sections 1.502, 1.503, and 1.509, but you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every 2 years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (21 CFR 1.512(b)(3)(i)).
We also note that certain foods imported from your foreign supplier, (b)(4), are currently subject to detention without physical examination (DWPE) based on multiple Import Alerts (IA):
IA #45-02, for foods containing illegal and/or undeclared colors;
IA #99-08, for processed human and animal foods for pesticides
IA #99-19, for food products due to the presence of Salmonella;
IA #99-21, for food products containing sulfites.
Therefore, when you import these foods subject to DWPE as described in these identified IAs, they are subject to refusal of admission pursuant to Section 801(a)(3) in that the food appears to be adulterated and/or misbranded per the guidance in the respective IAs. This information should be taken into consideration when you are evaluating your suppliers and developing your FSVP.
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 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 # 619282 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/
Theresa Smedley
Acting Program Division Director
Division of Northeast Imports
Owner
Patidar Trade, Inc.
1463 Finnegan Lane
North Brunswick, NJ 08902
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
January 6, 2022
Re: CMS # 619282
Dear Mr. Rajesh Patel:
On August 10 through September 10, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Patidar Trade, Inc. located at 1463 Finnegan Lane, North Brunswick, NJ. We also conducted an inspection on August 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-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 the foods you import. 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 September 10, 2021.
Your significant violations of the FSVP regulation are as follows:
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, maintain, and follow an FSVP for any of the foods you import including each of the following food products:
Wheat flour imported from (b)(4)
Rice flour imported from (b)(4)
Phool makhana imported from (b)(4)
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. 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 for which you appear to be in violation of section 805. We may place the foods you import into the United States 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)).
Additionally, we offer the following comments:
In your response to the issued Form FDA 483a from the previous inspection, you stated your firm meets the definition of very small importer as defined in 21 CFR 1.500, and therefore is subject to the modified FSVP requirements in 21 CFR 1.512. During the most recent inspection, you did not provide documentation that you meet the definition of very small importer in §1.500 with respect to the foods you import. If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer as required by 21 CFR 1.512(b)(1)(i). If this section applies and you choose to comply with the requirements in paragraph (b) of this section, you also are required to comply with the requirements in sections 1.502, 1.503, and 1.509, but you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every 2 years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (21 CFR 1.512(b)(3)(i)).
We also note that certain foods imported from your foreign supplier, (b)(4), are currently subject to detention without physical examination (DWPE) based on multiple Import Alerts (IA):
IA #45-02, for foods containing illegal and/or undeclared colors;
IA #99-08, for processed human and animal foods for pesticides
IA #99-19, for food products due to the presence of Salmonella;
IA #99-21, for food products containing sulfites.
Therefore, when you import these foods subject to DWPE as described in these identified IAs, they are subject to refusal of admission pursuant to Section 801(a)(3) in that the food appears to be adulterated and/or misbranded per the guidance in the respective IAs. This information should be taken into consideration when you are evaluating your suppliers and developing your FSVP.
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 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 # 619282 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/
Theresa Smedley
Acting Program Division Director
Division of Northeast Imports
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