The first quarter of 2020 is behind us, and with it, a fresh batch of warning letters sent by the FDA to food and dietary supplement companies.

We’ve compiled a snapshot of all of the letters that posted from January through the end of March and organized them by category provided by the FDA for your convenience. In total, 22 warning letters were sent for various infractions, ranging from FSVP violations to Insanitary Conditions.

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Foreign Supplier Verification Program (FSVP)

  • Lemond Trading Corp (Honolulu, HI) received a warning letter based on their response to 483s issued at inspections dated November 25 through November 26, 2019.
  • Swagath Home Foods LLC (Redmond, WA) received a warning letter based on their response to 483s issued at an inspection dated September 18, 2019. 
  • Nassif Wholesale LLC (Palm Springs, FL) received a warning letter based on the outcome of an inspection dated January 31, 2020.
  • Sunrise Distributors Inc. (Elk Grove Village, IL) received a warning letter based on their failure to respond to 483 issued at inspections dated July 9, 2019, and December 5, 2019.
  • Hindy Import Inc. (El Cajon, CA) received a warning letter based on the outcome of an inspection dated May 7, 2019, and subsequent follow up.
  • Mission LLC (Renton, WA) received a warning letter based on the outcome of inspections dated August 5 through August 7, 2020, and subsequent follow-up.

Seafood HACCP/CGMP For Foods Adulterated/Insanitary Conditions

  • CATSMO LLC (Wallkill, NY) received a warning letter due to their response to 483s issued at inspections dated November 18 through December 12, 2019, and subsequent follow-up. 
  • Shung Kee Food Co., Ltd. (New York, NY) received a warning letter due to their response to 483s issued at inspections dated: October 21 through October 22, 2019; October 28 through 31, 2019; November 6; November 15, 2019; and subsequent follow up.
  • Fuji Food Products, Inc. (Santa Fe Springs, CA) received a warning letter due to their response to 483s issued at inspections dated November 12 through December 4, 2019, and subsequent follow-up.
  • Apia Export Fish Packers LTD (Apia, Samoa) received a warning letter based on the outcome on an inspection dated August 26 through 27, 2019.
  • Neptunus Seafood B.V. (Netherlands) received a warning letter based on their response to 483s issued on an inspection dated October 22 through 23, 2019.

New Drug/Labeling/Misbranded 

  • KetoKerri LLC (Chandler, AZ) received a warning letter after a review of their website showed claims that establish their products as drugs intended for use in the cure, mitigation, treatment, or prevention of disease.  

CGMP/Dietary Supplement/Adulterated/Misbranded

  • Marco Pharma International LLC (Roseburg, OR) received a warning letter due to their response to 483s issued at inspections dated May 14 through May 22, 2019, and subsequent follow-up. Bulletproof 360 Inc. (Seattle, WA) received a warning letter due to their response to 483s issued at inspections dated August 12 through August 28, 2019, and September 3 through September 6, 2019, and subsequent follow-up.

CGMP/Food/Prepared, Packed, or Held Under Insanitary Conditions/Adulterated

  • Cerreta Candy Company, Inc. (Glendale, AZ) received a warning letter due to their response to 483s issued at inspections dated August 19 through August 26, 2019, and subsequent follow-up.
  • Cafe Valley Bakery, LLC (Phoenix, AZ) received a warning letter due to their response to 483s issued at inspections dated November 5 through December 17, 2019, and subsequent follow-up. 
  • Gourmet Catering to Go, LLC (Nashville, TN) received a warning letter based on the outcome of inspections dated September 27 through October 17, 2019, and subsequent follow-up.

CGMP/Medicated Feeds/Adulterated

  • Cargill Incorporated (Wayzata, MN) received a warning letter due to their response to 483s issued at inspections dated June 4 through June 11, 2019, and subsequent follow-up.

CGMP/Food for Animals/Prepared, Packed, or Held Under Insanitary Conditions/Adulterated

  • Bravo Packaging, Inc. (Carneys Point, NJ) received a warning letter based on the outcome of inspections dated July 22 through July 24, 2019, and August 6, 2019.

Acified Foods/ Acid Canned Food Regulation

  • GuiLin SanYang Dietary Ecological Industry Co.Ltd. (Zhuangzuzizhiqu, China) received a warning letter due to their response to 483s issued at an inspection dated September 4, 2019, and subsequent follow-up.  

Acified Foods/Emergency Permit Control/Adulterated/Misbranded

  • TP. Food Canning Ltd., Part. (Chiang Mai, Thailand) received a warning letter due to lack of a response to 483s issued at an inspection dated September 16 through September 17, 2019.

Low Acid Canned Food Regulation/Adulterated

  • Yakseon Food Agricultural Co. LTD (South Korea) received a warning letter due to their response to 483s issued at an inspection dated October 17 through October 18, 2019, and subsequent follow-up.

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Download your copy of THE FDA INSPECTION LANDSCAPE IN MID-2020 AND A LOOK AT VIRTUAL INSPECTION

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FY2018-FY2020 GMP data for Lonza & Catalent

Top GMP primary citations

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Turning Failure into Success

Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble

What you will learn:

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Quality Management Systems for Small Pharma and Biotech Firms

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GMP data from FY2017 to FY2020 for the Asia-Pacific region

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An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

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Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Webinar: Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Presented by Paul Smith, Agilent Technologies on Aug. 26, 2020

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Changing Medical Device Regulations

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Combination Product Report

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