Warning Letters
Learn about the types of warning letters on FDA's website.
- Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
- To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.
- Frequently requested records may be accessed on the Reading Room page.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Bo Wah Enterprises Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | … Bo Wah Enterprises Inc … August 13, 2026 WARNING LETTER Re: CMS 736539 Dear Mr. … Program (FSVP) inspection of BO WAH ENTERPRISES INC, 1037 Maunakea St, Honolulu, HI 96817-5130. This … Mushroom, imported from (b)(4) located in (b)(4) (b)(4) Sesame Paste, imported from (b)(4) located in (b)(4) For … | ||||
| Shouly Import Corp. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | … including each of the following foods: Roasted White Sesame imported from (b)(4) , located in (b)(4) Feta 500GM … | ||||
| Shang Hao Jia, Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | … Shang Hao Jia, Inc. … March 18, 2026 WARNING LETTER Re: CMS #720238 Dear Mr. … Verification Programs (FSVP) inspection of Shang Hao Jia, Inc. located at 2311 Merced Ave, South El Monte, CA 91801. … 2025, after you were notified of the undeclared allergen (sesame) on the product label. During our inspection, you told … | ||||
| Nutratech, LLC | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded |
… 321(qq)] defines milk, egg, fish, Crustacean shellfish, sesame, tree nuts, wheat, peanuts, and soybeans, as well as … | ||||
| Aversa's Italian Bakery | Human Foods Program | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated | … analytical results confirmed the presence of unintended sesame in this product. Based on FDA’s inspectional findings … products, including but not limited to Hoagie Rolls with Sesame. However, you did not have a food safety plan with the … products that contain allergens (such as wheat, milk, and sesame). Products containing different allergen profiles are … | ||||
| Great One Trading Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | … Great One Trading Inc. … WARNING LETTER RE: CMS# 728716 Dear Johnny Lau: On … Program (FSVP) inspection of Great One Trading Inc. located at 4120 2nd Ave, Brooklyn, NY 11232-3315. We … Mooncake imported from (b)(4) , located in (b)(4) . Sesame Tapioca Cracker imported from (b)(4) , located in … | ||||
| RSV Pita, Inc. DBA Pita Pan Bakery | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | … RSV Pita, Inc. DBA Pita Pan Bakery … December 18, 2025 WARNING LETTER … homepage at www.fda.gov. Further, your Jerusalem Bagel, Sesame Pita Bread, and Challah Sesame Bread products are misbranded within the meaning of … | ||||
| Hearthy Foods, Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded |
… Hearthy Foods, Inc. … February 10, 2026 CMS #712415 Dear Mr. Surti: The U.S. … shellfish, tree nuts, wheat, peanuts, soybeans, and sesame as well as any food ingredient that contains protein … | ||||
| A TO Z Distributor Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | … A TO Z Distributor Inc … 02/10/2026 WARNING LETTER RE: CMS# 722245 Dear Ms. … Program (FSVP) inspection of A TO Z Distributor Inc. located at 2445 E 65th Street, Brooklyn, NY 11234-6717. … Original imported from (b)(4) , located in (b)(4) Roasted Sesame Seeds imported from (b)(4) , located in (b)(4) (b)(4) … | ||||
| Middle East/Soli's Baking Company, Inc. dba Middle East Baking Co. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | … Middle East/Soli's Baking Company, Inc. dba Middle East Baking Co. … July 25, 2025 WARNING … one live apparent beetle were observed on the leftmost “Sesame product only” mixer base, directly behind, and … 20, 2024, two live apparent beetles were observed in the sesame disperser directly above pita sheeter line, which is … |