Tiao Peng Trading, Inc.of Hayward, CA did not have an FSVP for these imported items a) Canned black beans, canned red beans, and canned fruit, b) Fish snack foods, and c)Custard cake. They also did bit gave documentation that thermally processed low‐acid foods packaged in hermetically sealed containers (low-acid canned foods) was produced in accordance with Low Acid Food Requirements (21 CFR part 113).
Express Trading International Inc.of San Diego did not have an FSVP for a) Canned Coconut Milk and b) Aloe Vera Drink Pomegranate.
FSVP (Foreign Supplier Verification Program) are required by importers to demonstrate that product had been produced to US food safety standards.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tiao-peng-trading-inc-603865-05192020
Tiao Peng Trading, Inc.
MARCS-CMS 603865 — May 19, 2020
Recipient:
Danai Kietikul
Owner
Tiao Peng Trading, Inc.
31760 Hayman St.
Hayward, CA 94544
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
May 19, 2020
Re: CMS #603865
Dear Mr. Danai Kietikul:
On January 14‐17, 2020, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at Tiao Peng Trading, Inc. located at 31760 Hayman St., Hayward, CA 94544. We also conducted an inspection on September 12, 2017. 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 your canned black beans, canned red beans, and canned fruit imported from (b)(4), located in (b)(4); fish snack foods imported from (b)(4), located in (b)(4); and custard cake 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 FSVPs for your pickled mustard imported from (b)(4), located in (b)(4); curry gravy, imported from (b)(4), located in (b)(4); and tom yum soup paste 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 inspection on September 12, 2017 and the follow‐up inspection on January 14 ‐17, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response dated January 27, 2020, where you provided a one‐page letter stating that you are in the process of gathering data and documents to develop FSVP, document to verify that the food was produced according to the low‐acid canned foods regulations, procedures approving foreign suppliers based on evaluation, and procedures verifying foreign suppliers’ activities. However, we are unable to evaluate the adequacy of your corrective actions because you did not include supporting documentation, such as examples of implemented procedures.
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 each of the following foods:
a. Canned black beans, canned red beans, and canned fruit imported from (b)(4), located in (b)(4).
b. Fish snack foods imported from (b)(4), located in (b)(4).
c. Custard cake imported from (b)(4), located in (b)(4).
2. For thermally processed low‐acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards that are controlled by following 21 CFR part 113, you must verify and document that the food was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1). You did not verify and document that your curry gravy, a low‐acid canned food, was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1).
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 suppliers of curry gravy and tom yum soup paste imported from (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 1.506(a)(1).
5. 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).
6. You did not 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). For example, you did not conduct and document (or obtain documentation of) one or more of such supplier verification activities for your foreign supplier (b)(4) before importing pickled mustard and periodically thereafter, for your foreign supplier (b)(4). before importing tom yum soup paste and periodically thereafter, or for your foreign supplier (b)(4). before importing curry gravy and periodically thereafter.
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 these violations, 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 canned black beans, canned red beans, and canned fruit imported from (b)(4); fish snack foods imported from (b)(4); custard cake imported from (b)(4); pickled mustard imported from (b)(4); curry gravy, imported from (b)(4); and tom yum soup paste imported from (b)(4). We may place the foods from the identified foreign suppliers 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 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: Debbie Giang, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Compliance Officer Giang via phone at (562) 256‐9235 or via email at debbie.giang@fda.hhs.gov. Please reference CMS #603865 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/
Dan R. Solis
Program Division Director
Division of West Coast Imports
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/express-trading-international-inc-606776-07022020
Express Trading International Inc.
MARCS-CMS 606776 — July 02, 2020
Recipient:
Salwan (Sam) Shayota
Owner
Express Trading International Inc.
401 B Street, Ste 2310
San Diego, CA 92101
United States
Issuing Office:
Division of Southeast Imports
United States
WARNING LETTER
July 2, 2020
Re: CMS #606776
Dear Mr. Shayota,
On February 19, 2020, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at 401 B Street, Suite 2310, San Diego, CA. We also conducted an inspection on July 17, 2018. 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 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 Canned Coconut Milk and Aloe Vera Drink Pomegranate imported from your foreign supplier, (b)(4), located in (b)(4). Your firm did not have FSVPs for these products. 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 July 17, 2018 and our follow-up inspection on February 19, 2020, our investigator provided you each time with a Form 483a, citing FSVP observations.
You responded to the initial Form 483a on July 18, 2018, stating that you intended “to have a fully-developed FSVP in writing no later than September 1st, 2018.” On August 31, 2018, you stated that your FSVP would be prepared by October 1, 2018. We received your responses to the most recent Form 483a on March 5, 2020, April 8, 2020 and April 22, 2020. Your response on March 5 stated that your “[c]urrent estimated time of completion is about 6 weeks from now.” Your response on April 8 stated that your “pending timeframe for complete response is 6 weeks from now, hopefully.” Your response on April 22 stated that you “have been in process of getting specific HACCP plans from each supplier so that (b)(4) can crate a proper FSVP.” No further correspondence has been received to date.
These responses do not provide sufficient information to evaluate your plan or progress because you did not provide any supporting documentation.
Your significant violations of the FDVP 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 an FSVP for each of the following foods:
• Canned Coconut Milk imported from (b)(4), located in (b)(4).
• Aloe Vera Drink Pomegranate products imported from (b)(4), located in (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.
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 canned coconut milk and Aloe Vera Drink Pomegranate, imported from (b)(4), located in (b)(4). We may place these foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import these 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 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: Alexander Lopez
Director, Compliance Branch
U.S. Food and Drug Administration
4040 North Central Expressway, Suite 300
Dallas, TX 7520
If you have any questions regarding this letter prior to your written response, you may contact Barbara Rincon, Compliance Officer at telephone number (619) 941-3691 or via email at Barbara.Rincon@fda.hhs.gov. Please reference CMS #606776 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/
Todd Cato
Division Director
Division of Southwest Imports
Express Trading International Inc.of San Diego did not have an FSVP for a) Canned Coconut Milk and b) Aloe Vera Drink Pomegranate.
FSVP (Foreign Supplier Verification Program) are required by importers to demonstrate that product had been produced to US food safety standards.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tiao-peng-trading-inc-603865-05192020
Tiao Peng Trading, Inc.
MARCS-CMS 603865 — May 19, 2020
Recipient:
Danai Kietikul
Owner
Tiao Peng Trading, Inc.
31760 Hayman St.
Hayward, CA 94544
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
May 19, 2020
Re: CMS #603865
Dear Mr. Danai Kietikul:
On January 14‐17, 2020, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at Tiao Peng Trading, Inc. located at 31760 Hayman St., Hayward, CA 94544. We also conducted an inspection on September 12, 2017. 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 your canned black beans, canned red beans, and canned fruit imported from (b)(4), located in (b)(4); fish snack foods imported from (b)(4), located in (b)(4); and custard cake 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 FSVPs for your pickled mustard imported from (b)(4), located in (b)(4); curry gravy, imported from (b)(4), located in (b)(4); and tom yum soup paste 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 inspection on September 12, 2017 and the follow‐up inspection on January 14 ‐17, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response dated January 27, 2020, where you provided a one‐page letter stating that you are in the process of gathering data and documents to develop FSVP, document to verify that the food was produced according to the low‐acid canned foods regulations, procedures approving foreign suppliers based on evaluation, and procedures verifying foreign suppliers’ activities. However, we are unable to evaluate the adequacy of your corrective actions because you did not include supporting documentation, such as examples of implemented procedures.
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 each of the following foods:
a. Canned black beans, canned red beans, and canned fruit imported from (b)(4), located in (b)(4).
b. Fish snack foods imported from (b)(4), located in (b)(4).
c. Custard cake imported from (b)(4), located in (b)(4).
2. For thermally processed low‐acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards that are controlled by following 21 CFR part 113, you must verify and document that the food was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1). You did not verify and document that your curry gravy, a low‐acid canned food, was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1).
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 suppliers of curry gravy and tom yum soup paste imported from (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 1.506(a)(1).
5. 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).
6. You did not 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). For example, you did not conduct and document (or obtain documentation of) one or more of such supplier verification activities for your foreign supplier (b)(4) before importing pickled mustard and periodically thereafter, for your foreign supplier (b)(4). before importing tom yum soup paste and periodically thereafter, or for your foreign supplier (b)(4). before importing curry gravy and periodically thereafter.
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 these violations, 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 canned black beans, canned red beans, and canned fruit imported from (b)(4); fish snack foods imported from (b)(4); custard cake imported from (b)(4); pickled mustard imported from (b)(4); curry gravy, imported from (b)(4); and tom yum soup paste imported from (b)(4). We may place the foods from the identified foreign suppliers 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 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: Debbie Giang, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Compliance Officer Giang via phone at (562) 256‐9235 or via email at debbie.giang@fda.hhs.gov. Please reference CMS #603865 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/
Dan R. Solis
Program Division Director
Division of West Coast Imports
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/express-trading-international-inc-606776-07022020
Express Trading International Inc.
MARCS-CMS 606776 — July 02, 2020
Recipient:
Salwan (Sam) Shayota
Owner
Express Trading International Inc.
401 B Street, Ste 2310
San Diego, CA 92101
United States
Issuing Office:
Division of Southeast Imports
United States
WARNING LETTER
July 2, 2020
Re: CMS #606776
Dear Mr. Shayota,
On February 19, 2020, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at 401 B Street, Suite 2310, San Diego, CA. We also conducted an inspection on July 17, 2018. 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 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 Canned Coconut Milk and Aloe Vera Drink Pomegranate imported from your foreign supplier, (b)(4), located in (b)(4). Your firm did not have FSVPs for these products. 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 July 17, 2018 and our follow-up inspection on February 19, 2020, our investigator provided you each time with a Form 483a, citing FSVP observations.
You responded to the initial Form 483a on July 18, 2018, stating that you intended “to have a fully-developed FSVP in writing no later than September 1st, 2018.” On August 31, 2018, you stated that your FSVP would be prepared by October 1, 2018. We received your responses to the most recent Form 483a on March 5, 2020, April 8, 2020 and April 22, 2020. Your response on March 5 stated that your “[c]urrent estimated time of completion is about 6 weeks from now.” Your response on April 8 stated that your “pending timeframe for complete response is 6 weeks from now, hopefully.” Your response on April 22 stated that you “have been in process of getting specific HACCP plans from each supplier so that (b)(4) can crate a proper FSVP.” No further correspondence has been received to date.
These responses do not provide sufficient information to evaluate your plan or progress because you did not provide any supporting documentation.
Your significant violations of the FDVP 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 an FSVP for each of the following foods:
• Canned Coconut Milk imported from (b)(4), located in (b)(4).
• Aloe Vera Drink Pomegranate products imported from (b)(4), located in (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.
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 canned coconut milk and Aloe Vera Drink Pomegranate, imported from (b)(4), located in (b)(4). We may place these foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import these 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 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: Alexander Lopez
Director, Compliance Branch
U.S. Food and Drug Administration
4040 North Central Expressway, Suite 300
Dallas, TX 7520
If you have any questions regarding this letter prior to your written response, you may contact Barbara Rincon, Compliance Officer at telephone number (619) 941-3691 or via email at Barbara.Rincon@fda.hhs.gov. Please reference CMS #606776 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/
Todd Cato
Division Director
Division of Southwest Imports
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