As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Gobwa Exotic Imports Inc.
Brooklyn, NY
An import company in New York is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Nov. 29, 2022, warning letter, the FDA described a July 5-21, 2022, Foreign Supplier Verification Program (FSVP) inspection of Gobwa Exotic Imports Inc. in Brooklyn, NY.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations which resulted in the issuance of an FDA Form 483a. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Plantain, breadfruit, peppers (hot), taro, bay spice, and chocolate/cocoa imported from (redacted), located in (redacted)
- Breadfruit imported from (redacted), located in (redacted)
- Breadfruit and peppers (hot) imported from (redacted), located in the (redacted)
- 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 (redacted), located in (redacted)
- Plums, mangos, pimiento peppers, taro leaves, vanilla extract, mixed spice and seasonings, and coconut milk imported from (redacted), located in (redacted)
- Breadfruit imported from (redacted), located in the (redacted)
- Bananas, papayas, plantains, genip, roselle, breadfruit, beans/corn/peas, pimiento peppers, celery, sorrel, sugar cane, yams, potatoes, taro, and chocolate/cocoa imported from (redacted), located in the (redacted)
- Breadfruit imported from (redacted), located in the (redacted)
The firm imports fresh produce, that is “covered produce.” As an importer of covered produce, they must have an FSVP that demonstrates that their 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 and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.
2. The firm must conduct a written hazard analysis for each type of food they import to determine whether there are any hazards requiring a control. Although they may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, they must document their review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual. They have not demonstrated compliance with this requirement. Specifically, during the inspection they provided copies of hazard analyses that were conducted by their foreign suppliers for the fresh bananas and fresh soursop that they imported from (redacted), located in (redacted), and for the fresh hot peppers that they imported from (redacted), located in the (redacted). FDA investigators asked if they had reviewed these hazard analyses and the firm responded that they received handwritten copies and had transcribed them. However, they did not provide documentation that they reviewed and assessed their foreign supplier’s hazard analysis, including whether it was conducted by a qualified individual.
3. The firm did not document that they conducted an evaluation of the supplier’s performance and the risk posed by the food and document their approval of their foreign supplier on the basis of that evaluation. During the inspection, a representative of the firm stated that they do not have any evaluation procedures or documentation showing that they evaluated fresh soursop and fresh bananas imported from (redacted) in (redacted) and fresh hot pepper imported from (redacted) in the (redacted). FDA investigators asked them how they evaluate their suppliers and explained key requirements of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. They stated that in the past, they would visit their suppliers, but they have not done so in 10 years. They stated they are aware that their foreign suppliers (redacted) and do not (redacted), and they received test records from their suppliers (redacted). As part of their response on Aug. 8, 2022, they included a Laboratory Test Report (redacted) from (redacted) and a (redacted) report from (redacted), as well as a (redacted) for hot peppers from (redacted). The firm further explained that they request a (redacted) from their suppliers every (redacted), which they review for any changes in production process or changes in appearance of the product. To the extent that the (redacted) and test reports they described and provided are part of their evaluation of their suppliers, they did not document their evaluation of each foreign supplier’s performance and the risk posed by the food, and they did not document their approval, as required.
4. They did not meet the requirements to perform foreign supplier verification activities for the products they import. Specifically, they did not document their determination or performance of appropriate foreign supplier verification activities for fresh soursop and fresh bananas that they import from (redacted) located in (redacted) or for fresh hot peppers that they import from (redacted) located in the (redacted). During the inspection, they explained that about every (redacted), they request that (redacted) and (redacted) provide them with (redacted) the production process which they review for any changes to the production process or changes in appearance of the product. The firm also provided, as part of their response dated Aug. 8, 2022, a Laboratory Test Report for (redacted) from (redacted) and a (redacted) report and (redacted) for hot peppers from (redacted). Although these videos and reports may provide information relevant to verification activities, they did not include any description of audit procedures or conclusions, or indicate that the applicable FDA food safety regulations were considered. Furthermore, they did not establish written procedures for ensuring that appropriate supplier verification activities are conducted, and they did not document their determination of the appropriate supplier verification activity.
The full warning letter can be viewed here.
Zuland Distributor Corp.
Imperial Beach, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Oct. 17, 2022, warning letter, the FDA described a June 28 and July 8, 2022, Foreign Supplier Verification Program (FSVP) inspection of Zuland Distributor Corp in Imperial Beach, CA.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations which resulted in the issuance of an FDA Form 483a. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Jicama imported from (redacted), located in (redacted)
- Jack fruit imported from (redacted), located in (redacted)
- Long beans imported from (redacted), located in (redacted)
The full warning letter can be viewed here.
Euphoria Fancy Food Inc.
Brooklyn, NY
An import company in New York is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Nov. 21, 2022, warning letter, the FDA described a July 19 through Aug. 4, 2022, Foreign Supplier Verification Program (FSVP) inspection of Euphoria Fancy Food Inc. in Brooklyn, NY.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations which resulted in the issuance of an FDA Form 483a. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Sandwich Spread imported from (redacted)
- Processed Cheese imported from (redacted)
- Biscuits Butter with Nuts imported from (redacted)
The full warning letter can be viewed here.
Cecilia Alvarez
McAllen, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Nov. 22, 2022, warning letter, the FDA described a July 26-28, 2022, Foreign Supplier Verification Program (FSVP) inspection of Cecilia Alvarez in McAllen, TX.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations which resulted in the issuance of an FDA Form 483a. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Potato Chips and Cookies imported from foreign supplier (redacted) located in (redacted)
- Corn Chips imported from foreign supplier (redacted) located in (redacted)
The full warning letter can be viewed here.
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