- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. McDonald Romain
- Gobwa Exotic Imports Inc.
1127 Nostrand Ave.
Brooklyn, NY 11225
- Issuing Office:
- Division of Northeast Imports
Re: CMS 641031
Dear Mr. McDonald Romain:
On July 5, 2022, through July 21, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Gobwa Exotic Imports Inc., located at 1127 Nostrand Ave., Brooklyn, NY 11225. We also conducted an inspection on February 9, 2021, through March 4, 2021. 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 acknowledge receipt of your response to the Form FDA 483a, dated August 8, 2022. In your response, you stated that your first step was to contact consultants to assist you in furnishing FSVPs within 30 business days. However, we are unable to evaluate the adequacy of this portion of the response because you did not provide documentation of specific actions you or your consultants have taken to develop your FSVPs.
Your response also stated that the “(b)(4) will provide [you] with an auditor to do in person inspection” (b)(4), “to ensure they meet sanitary guidelines.” You further stated that you are researching an auditor (b)(4) to conduct inspections (b)(4). To the extent that the audits you reference in your response will be part of your activities to demonstrate compliance with the FSVP regulation, we are unable to evaluate the adequacy of your response because you did not provide relevant details, including the standards against which these audits will be performed or how you intend to integrate them into your FSVPs. Further, you did not indicate an expected completion date for these audits.
Your response also included a (b)(4) used at (b)(4), dated July 26, 2022, and for your FSVP for fresh hot peppers imported from (b)(4), you provided a (b)(4), dated “06/05/2022-08/05/2022” and a (b)(4) “15-07-2022”. We further address these records and your response below.
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 part 1.502(a). Specifically, you did not develop, maintain, and follow an FSVP for the following foods you import:
- Plantain, breadfruit, peppers (hot), taro, bay spice, and chocolate/cocoa imported from (b)(4), located in (b)(4)
- Breadfruit imported from (b)(4), located in (b)(4)
- Breadfruit and peppers (hot) imported from (b)(4), located in the (b)(4)
- Corn (whole grain), corn (milled), tapioca starch product, cake without custard or cream filling, other bakery products, apples, gooseberries (berry and dried or paste), avocados, plums, papayas, plantains, breadfruit, jackfruit, mangos, guava, sweetsop, nuts, okra, peppers (hot), Chinese okra, cabbage, sorrel, taro leaves, seaweed, leaf and stem vegetables, root and tuber vegetable, taro (dasheen), cinnamon, nutmeg, bay, mace, mixed spices, pepper, natural extract or flavor, vanilla extract, tea, soft candy, cocoa beans, cocoa butter, and chocolate/cocoa imported from (b)(4), located in (b)(4)
- Plums, mangos, pimiento peppers, taro leaves, vanilla extract, mixed spice and seasonings, and coconut milk imported from (b)(4), located in (b)(4)
- Breadfruit imported from (b)(4), located in the (b)(4)
- Bananas, papayas, plantains, genip, roselle, breadfruit, beans/corn/peas, pimiento peppers, celery, sorrel, sugar cane, yams, potatoes, taro, and chocolate/cocoa imported from (b)(4), located in the (b)(4)
- Breadfruit imported from (b)(4), located in the (b)(4)
You import fresh produce, that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your 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 419 of the FD&C Act (21 U.S.C. § 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).
2. 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(a). 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. You have not demonstrated compliance with this requirement. Specifically, during the inspection you provided copies of hazard analyses that were conducted by your foreign suppliers for the fresh bananas and fresh soursop that you imported from (b)(4), located in (b)(4), and for the fresh hot peppers that you imported from (b)(4), located in the (b)(4). Our investigator asked if you had reviewed these hazard analyses and you responded that you received handwritten copies and had transcribed them. However, you did not provide documentation that you reviewed and assessed your foreign supplier’s hazard analysis, including whether it was conducted by a qualified individual, as required by 21 CFR 1.504(d).
3. You did not document that you conducted an evaluation of the supplier’s performance and the risk posed by the food, in accordance with 21 CFR 1.505(a), and document your approval of your foreign supplier on the basis of that evaluation, as required by 21 CFR 1.505(b). During the inspection, a representative of your firm stated that you do not have any evaluation procedures or documentation showing that you evaluated fresh soursop and fresh bananas imported from (b)(4) in (b)(4) and fresh hot pepper imported from (b)(4) in the (b)(4). Our investigator asked you how you evaluate your suppliers and explained key requirements of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112). You stated that in the past, you would visit your suppliers, but you have not done so in 10 years. You stated you are aware that your foreign suppliers (b)(4) and do not (b)(4), and you received test records from your suppliers (b)(4). As part of your response on August 8, 2022, you included a Laboratory Test Report (b)(4) from (b)(4) and a (b)(4) report from (b)(4), as well as a (b)(4) for hot peppers from (b)(4). You further explained that you request a (b)(4) from your suppliers every (b)(4), which you review for any changes in production process or changes in appearance of the product. To the extent that the (b)(4) and test reports you described and provided are part of your evaluation of your suppliers, you did not document your evaluation of each foreign supplier’s performance and the risk posed by the food in accordance with 21 CFR 1.505(a)(2), and you did not document your approval, as required by 21 CFR 1.505(b).
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 foreign supplier verification activities for fresh soursop and fresh bananas that you import from (b)(4) located in (b)(4) or for fresh hot peppers that you import from (b)(4) located in the (b)(4). During the inspection, you explained that about every (b)(4), you request that (b)(4) and (b)(4) provide you with (b)(4) the production process which you review for any changes to the production process or changes in appearance of the product. You also provided, as part of your response dated August 8, 2022, a Laboratory Test Report for (b)(4) from (b)(4) and a (b)(4) report and (b)(4) for hot peppers from (b)(4). Although these videos and reports may provide information relevant to verification activities, you did not include any description of audit procedures or conclusions, or indicate that the applicable FDA food safety regulations were considered. Furthermore, 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).
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 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:
During the inspection, you provided hazard analyses that were conducted by your foreign suppliers for the fresh bananas and fresh soursop that you imported from (b)(4), located in (b)(4), and for the fresh hot peppers that you imported from (b)(4), located in the (b)(4).
To the extent you intend to use these hazard analyses to comply with FSVP requirements, when you conduct and document your review and assessment per 21 CFR 1.504(d), we recommend that you also obtain and maintain documentation from your supplier, (b)(4), of information that demonstrates that their described activity of (b)(4) is sufficient as a control for Pseudococcidae (Mealybug) without introducing any new risk factors (such as internalization – the introduction of foodborne pathogens into edible parts of fresh produce), as well as supplier documentation of controls used to ensure that the (b)(4) met the specified criteria throughout the treatment period. If, as stated, your supplier is using (b)(4), then periodic (e.g., annual) documentation that attests to the supplier’s (b)(4) quality would also be needed.
Additionally, regarding your supplier’s described use of pressure washing, especially if performed at (b)(4), such pressure has the potential to spread contamination widely throughout the immediate use area. Further, this practice could damage the integrity of the produce commodity’s skin which also could introduce pathogen contamination. We recommend that you evaluate the appropriateness of using such high pressure to wash the produce, including consideration of how the supplier ensures that this activity does not contribute to increased potential for contamination of the food.
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 FSVPs, records to demonstrate implementation of your FSVPs), 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 working 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: David Trent-Carlson, Compliance Officer, Division of Northeast Imports: ORAOEIONEIMPORTSWLRESPONSES@fda.hhs.gov. Please also cc (carbon copy) David.Trent-Carlson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Trent-Carlson via email at David.Trent-Carlson@fda.hhs.gov. Please reference CMS # 641031 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Anna M. Alexander
Acting Program Division Director
Division of Northeast Imports