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.
La Aldea Distributors Inc.
San Antonio, 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 Jan 27, 2023, warning letter, the FDA described an Oct. 20 through Nov. 1, 2022, Foreign Supplier Verification Program (FSVP) inspection of La Aldea Distributors Inc in San Antonio, TX.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.
The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for any of the foods they import, including the following foods:
- Quince paste imported from (redacted)
- Honey from imported from (redacted)
- Guava jam imported from (redacted)
The full warning letter can be viewed here.
Five Star Trading IL Inc.
Chicago, IL
An import company in Illinois is on notice from the FDA for not having FSVPs for a number of imported food products.
In a March 29, 2023, warning letter, the FDA described a Nov. 21 through Dec. 12, 2022, Foreign Supplier Verification Program (FSVP) inspection of Five Star Trading IL, Inc. in Chicago, IL.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.
The significant violations are as follows:
1. The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop, maintain, and follow an FSVP for the foods from the foreign suppliers indicated in the attached list.
2. The firm did not meet the requirement to conduct and document (or obtain documentation of) one or more of the supplier verification activities for each foreign supplier before importing the food and periodically thereafter. Specifically, they did not conduct and document (or obtain documentation of) one or more such supplier verification activities for their foreign suppliers (redacted) and (redacted), both located in (redacted), before importing dried black peppercorn and dried black fungus, respectively, and periodically thereafter. During the inspection, they provided their FSVP for dried black peppercorn, which lists the verification activities that are to be conducted, including review of the following documents: Food Safety Plan or HACCP plan ((redacted) or upon reassessment); GMP program, SSOP, and third-party audits ((redacted)); certificate of analysis (microbiological and chemical) ((redacted)); and finished product testing (biological, chemical, physical) ((redacted)). However, while they provided records of finished product testing for dried black peppercorn, they did not document that they conducted any of the other listed verification activities. In their FSVP for dried black fungus, they documented that they determined verification activities were a review of the following documents: HACCP plan ((redacted) or upon reassessment); GMP program, SSOP, and third-party audits ((redacted)); certificate of analysis ((redacted)), and finished product testing (biological, chemical, physical) ((redacted)). However, in their email responses dated Dec. 27, 2022, their documentation of verification activities for dried black fungus included only copies of the foreign supplier’s HACCP plan and Sanitation Standard Operating Procedures.
3. The firm did not promptly document their review and assessment of the results of a verification activity that was conducted by another entity. Specifically, they did not have documentation that they reviewed and assessed the food product testing laboratory report for their dried black peppercorn imported from (redacted), and their foreign supplier’s HACCP plan and Sanitation Standard Operating Procedures for their dried black fungus imported from (redacted).
4. The firm must make all records required under this subpart available promptly to an authorized FDA representative, upon request, for inspection and copying. Upon FDA request, they must provide within a reasonable time an English translation of records maintained in a language other than English. However, they did not provide an English translation of the following FSVP document after the investigator’s request of the referenced document in English: finished product laboratory report for dried black peppercorn imported from (redacted). To date they have still not provided the requested translation of this document.
The full warning letter can be viewed here.
Santa Cruz Produce Inc.
Nogales, AZ
An import company in Arizona is on notice from the FDA for not having FSVPs for a number of imported food products.
In a March 8, 2023, warning letter, the FDA described a Nov. 14, 2022, Foreign Supplier Verification Program (FSVP) inspection of Santa Cruz Produce, Inc. in Nogales, AZ.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.
The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for any of the foods they import, including each of the following:
a. Fresh Mango, imported from (redacted)
b. Fresh Kabocha Squash, imported from (redacted)
c. Fresh Kabocha Squash, imported from (redacted)
The full warning letter can be viewed here.
Milky Way International Trading Corporation
Norwalk, 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 April 14, 2023, warning letter, the FDA described a Nov. 4 and Nov. 17, 2022, Foreign Supplier Verification Program (FSVP) inspection of Milky Way International Trading Corporation in Norwalk, CA.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.
The significant violations are as follows:
1. The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for the following foods:
- Mushroom, Common (Agaricus Bisporus), Pieces And Stems, Sliced imported from (redacted)
- Artichoke (Microgreen) and Artichoke (Leaf & Stem Vegetable) imported from (redacted), located in (redacted)
- Asparagus (Microgreen) and Asparagus (Leaf & Stem Vegetable) imported from (redacted), located in (redacted)
- Jerusalem Artichoke (Root & Tuber Vegetable) imported from (redacted), located in (redacted)
- Corn (Vegetable) imported from (redacted), located in (redacted)
- Orange (Citrus) imported from (redacted), located in (redacted)
- Pear (Core Fruit) imported from (redacted), located in (redacted)
- Peach (Pit Fruit) imported from (redacted), located in (redacted)
- Asparagus (Microgreen) and Asparagus (Leaf & Stem Vegetable) imported from (redacted), located in (redacted)
- Orange (Citrus) imported from (redacted), located in (redacted)
- Orange (Citrus) imported from (redacted), located in (redacted)
- Fruit Cocktail, Mixed Fruits imported from (redacted), located in (redacted)
- Peach, Jam, Jelly, Preserves, Marmalade, Butter Or Candied imported from (redacted), located in (redacted)
- Other Fruits And Subtropical/Tropical Fruit, Mixed, Toppings And Syrups imported from (redacted), located in (redacted)
- Mixed Fruit, N.E.C. imported from (redacted), located in (redacted)
- Peach (Pit Fruit) imported from (redacted), located in (redacted)
- Horseradish, Prepared imported from (redacted), located in (redacted)
- Bamboo Shoots (Microgreen) and Bamboo Shoots (Leaf & Stem Vegetable) imported from (redacted), located in (redacted)
- Heart Of Palm (Leaf & Stem Vegetable) imported from (redacted), located in (redacted)
2. The firm did not meet the requirements to perform foreign supplier verification activities for the products they import. Specifically, they did not meet the requirement to, before importing a food from a foreign supplier, determine and document which verification activity or verification activities, and the frequency with which such verification activity or activities must be conducted, are needed to provide adequate assurances that hazards requiring a control in the food they import have been significantly minimized or prevented. Their FSVPs for Strawberry Syrup and Blueberry Syrup imported from their foreign supplier (redacted), located in (redacted) and their FSVP for their Canned Coconut Cream imported from their foreign supplier (redacted), located in (redacted), require that their suppliers provide certain information, including food safety audit information, as part of their supplier verification activities. However, none of these FSVPs indicate the frequency with which this verification activity must be conducted. Further, when we asked if they documented the frequency of their verification activities, they did not provide an answer or any further records of this verification activity. In addition, while they may rely on third-party food safety audits as part of their foreign supplier verification activities, they must ensure the audit considers applicable FDA food safety regulations. For their foreign supplier (redacted), located in (redacted), which is their supplier for their Strawberry Syrup and Blueberry Syrup products, they provided an audit certificate performed by (redacted). While the certificate states that their supplier met the requirements of “Global Standard for Food Safety Issue 6: July 2011”, there is no indication that the audit considered applicable FDA food safety regulations and information relevant to the foreign supplier’s compliance with those regulations. Additionally, there is no indication that they reviewed or assessed the results of this audit using a qualified individual. The firm must also promptly review and assess the results of any third-party audit that constitutes a verification activity, document their review and assessment of the results of such activity, and take appropriate action if the results do not provide adequate assurances that the hazards requiring a control have been significantly minimized or prevented. The field in their FSVP for their Strawberry Syrup and Blueberry Syrup products, imported from their foreign supplier (redacted), located in (redacted), which indicates whether such products have an applicable food safety audit or certification, was not completed. FDA notes that the audit certificate for this supplier lists an expiry date of Jan. 19, 2021. When FDA investigators inquired about the expired audit certificate, the firm informed them that this was the most updated third-party audit and that they did not have other documents of verification activities for these products.
The full warning letter can be viewed here.
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