Funviralpark Gobwa Exotic Imports Inc.
Brooklyn, New York
New York importers have been notified by the FDA that they do not have FSVPs on many imported foods.
In its November 29, 2022 warning letter, the FDA described the Foreign Supplier Verification Program (FSVP) inspection of Gobwa Exotic Imports Inc., Brooklyn, New York, from July 5 through 21, 2022.
An FDA inspection found the company to be non-compliant with FSVP regulations, resulting in the issuance of FDA Form 483a. Some of the serious violations are:
The company did not develop, maintain and comply with the FSVP. Specifically, he did not create an FSVP for each of the following foods:
- Plantain, Breadfruit, Hot Bell Pepper, Taro, Bay Spice, Chocolate/Cocoa (Edited)located in (Edited)
- Breadfruit imported from (Edited)located in (Edited)
- Breadfruit and peppers (hot) imported from (Edited)is in (Edited)
- Corn (whole grain), corn (milled), tapioca starch products, cakes without custard or cream filling, other bakery products, apples, gooseberries (berries, dried or paste), avocados, plums, papaya, plantains, breadfruit, jack Fruits, mango, guava, sweetsop, nuts, okra, green peppers (hot), Chinese okra, cabbage, sorrel, taro leaves, seaweed, leaf and stem vegetables, root and tuber vegetables, taro (dashine), cinnamon, Nutmeg, bay leaves, mace, mixed spices, pepper, natural extracts or flavors, vanilla extract, black tea, soft candies, cocoa beans, cocoa butter, chocolate/cocoa. (Edited)located in (Edited)
- Plums, mangoes, pimiento peppers, taro leaves, vanilla extract, a mix of spices and seasonings, coconut milk imported from Japan. (Edited)located in (Edited)
- Breadfruit imported from (Edited)is in (Edited)
- Bananas, papaya, plantain, genip, roselle, breadfruit, beans/corn/peas, peppers, celery, sorrel, sugar cane, yams, potatoes, taro, chocolate/cocoa (Edited)is in (Edited)
- Breadfruit imported from (Edited)is in (Edited)
The company imports fresh produce, or “covered produce.” As an importer of covered produce, the supplier demonstrates that it produces food in compliance with processes and procedures that provide at least the same level of public health protection as required, and in accordance with the Code of Practice for Food Safety Standards. Must have his FSVP. Growing, harvesting, packing and storing agricultural products for human consumption.
2. Businesses must conduct a written hazard analysis for each type of food they import to determine whether there are any hazards requiring a control. Using a qualified person to review and evaluate a hazard analysis performed by another party can meet this requirement, but it is recommended to document that the hazard analysis was performed by a qualified person. including, document the review and evaluation of that hazard analysis. They have not demonstrated compliance with this requirement. Specifically, during the inspection, we provided copies of the hazard analyzes performed on imported fresh bananas and fresh soursop by our foreign suppliers. (Edited)located in (Edited)and for the fresh peppers they imported (Edited)is in (Edited)When asked if FDA investigators had reviewed these hazard analyses, the company responded that it received handwritten copies and transcribed them. However, they did not provide documentation indicating that they had reviewed and evaluated the foreign supplier’s risk analysis, including whether it had been conducted by a qualified individual.
3. The company has not documented that it has conducted an assessment of the supplier’s performance and the risks posed by the food and has not documented that it approved the foreign supplier based on that assessment. During the inspection, company representatives said they did not have evaluation procedures or documentation to show they had evaluated imported fresh soursop and fresh bananas. (Edited) of (Edited) Fresh chillies imported from (Edited) in the (Edited)Asked how they evaluate suppliers, FDA investigators described the key requirements of the standard for growing, harvesting, packing, and holding agricultural products for human consumption.They said they had previously intended to visit suppliers but had not done so in 10 years.They said they were aware of their foreign suppliers. (Edited) But don’t (Edited)received the test record from the supplier (Edited)A laboratory test report was included as part of the August 8, 2022 response. (Edited) from (Edited) and (Edited) report from (Edited),and (Edited) for chili pepper (Edited)The company further explained that they are requesting (Edited) from the supplier (Edited), to review changes in the production process or changes in product appearance.to that extent (Edited) The test reports they wrote and provided were part of their evaluation of their suppliers and they did not document their assessment of the performance of each foreign supplier and the risks posed by the food and We did not document the approval accordingly.
4. Failure to meet the requirements to conduct foreign supplier verification activities on the products it imports. Specifically, it did not document the determination or implementation of appropriate foreign supplier verification activities for source fresh soursop and fresh bananas. (Edited) is in (Edited) Or for the fresh peppers they import (Edited) It is in (Edited)During the inspection they explained everything (Edited)they request it (Edited) When (Edited) provide them (Edited) of A manufacturing process that reviews changes in the manufacturing process or changes in product appearance. The company also stated as part of its response dated 8 August 2022: (Edited) from (Edited) and (Edited) report and (Edited) for chili pepper (Edited)These videos and reports may provide information relevant to verification activities, but do not contain a description of audit procedures or conclusions, indicating that applicable FDA food safety regulations have been considered. Is not … Additionally, they did not establish written procedures to ensure that appropriate supplier verification activities were conducted and did not document their determination of appropriate supplier verification activities.
You can read the full text of the warning here.
Zooland Distributor Corporation.
Imperial Beach, California
A California importer has been notified by the FDA that many imported foods do not have an FSVP.
In its October 17, 2022 warning letter, FDA described the June 28 and July 8, 2022 Foreign Supplier Verification Program (FSVP) inspections of Zuland Distributor Corp, Imperial Beach, California.
An FDA inspection found the company to be non-compliant with FSVP regulations, resulting in the issuance of FDA Form 483a. Some of the serious violations are:
The company did not develop, maintain and comply with the FSVP. Specifically, he did not create an FSVP for each of the following foods:
- Jicama imported from (Edited)located in (Edited)
- Jackfruit imported from (Edited)located in (Edited)
- Imported from Nagamame (Edited)located in (Edited)
You can read the full text of the warning here.
Euphoria Fancy Foods Co., Ltd.
Brooklyn, New York
New York importers have been notified by the FDA that they do not have FSVPs on many imported foods.
In its November 21, 2022 warning letter, the FDA described a Foreign Supplier Verification Program (FSVP) inspection of Euphoria Fancy Food Inc. in Brooklyn, New York from July 19 through August 4, 2022. .
An FDA inspection found the company to be non-compliant with FSVP regulations, resulting in the issuance of FDA Form 483a. Some of the serious violations are:
The company did not develop, maintain and comply with the FSVP. Specifically, he did not create an FSVP for each of the following foods:
- Sandwich spreads imported from (Edited)
- Processed cheese imported from Japan (Edited)
- Biscuit butter with nuts imported from Japan (Edited)
You can read the full text of the warning here.
Cecilia Alvarez
McAllen, Texas
An import company in Texas has been notified by the FDA that it does not have an FSVP on many imported foods.
In its November 22, 2022 warning letter, the FDA described Cecilia Alvarez’s Foreign Supplier Verification Program (FSVP) inspection that took place July 26-28, 2022 in McAllen, Texas.
An FDA inspection found the company to be non-compliant with FSVP regulations, resulting in the issuance of FDA Form 483a. Some of the serious violations are:
The company did not develop, maintain and comply with the FSVP. Specifically, he did not create an FSVP for each of the following foods:
- Potato chips and cookies imported from overseas (Edited) is in (Edited)
- Corn chips imported from foreign suppliers (Edited) is in (Edited)
You can read the full text of the warning here.
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