FDA Enforcement and Recall Report Week of May 23
FDA Enforcement Report
**This week’s FDA enforcement report is tardy due to meetings on FDA’s White Oak campus (read a post on the visit here.)**
Each week the FDA reports on its enforcement activities. To help capture and digest that information the FDA Atty blog will post FDA recalls and warning letters.
It seems this week evidence of a the CRF frozen food recall has begun to slow down. Only 16 recall notices posted – a significant reduction. Still a full 12 (75%) are related to Listeria. It may be another two or three weeks before recall notices return to normal. Undeclared allergens are making a come-back with three posted this week related to milk.
Increased concern for compounding pharmacy continues and this week there is a recall related to sterility.
FDA Warning Letters
FDA Warning Letters post weekly but generally are issued earlier than posted. The most recent FDA Warning Letters involve only two center for tobacco letters for Family Smoking Prevention violations. This is a small number compared to most weeks.
A full nine (5) letters were issued for Good Manufacturing Practice (GMP or cGMP) issues. A week like this emphasizes how GMP issues are not confined to the FDA Form 483. As can been this week GMP compliance can range from adulteration (safety) concerns to labeling (mibsranding) issues.
An intersting cross-over letter appeared as well for a new animal drug. The Warning Letter was issued for drugs given to calves. The USDA FSIS enjoys primary jurisdiction over animal production, but the FDA over animal feed and drugs. This cross-jurisdiction is highlighted in the Bridgewater Warning Letter.
Please contact our Washington D.C. or Charlotte NC office with any FDA recall, Warning Letter or other enforcement questions.
FDA Recalls May 16 – May 24
|05/24/2016||C. J. Dannemiller Co.||Sunflower kernels||Listeria monocytogenes||C. J. Dannemiller Co.|
|05/24/2016||E.S. Foods||Products containing sunflower kernels||Listeria monocytogenes||E.S. Foods|
|05/23/2016||Alpine Valley, Wegmans, Flave Fitness, Gonzo, more||Products containing sunflower kernels||Listeria monocytogenes||First Source|
|05/22/2016||Hy-Vee||Trail mix products||Listeria monocytogenes||Hy-Vee, Inc.|
|05/21/2016||Albertsons-Safeway, Bashas, more||Oriental Salad with sesame ginger dressing||Listeria monocytogenes||Papa John’s Salad and Produce, Inc.|
|05/20/2016||Dakota Style||Sunflower kernels||Listeria monocytogenes||Dakota Style Foods, Inc.|
|05/20/2016||Hickory Harvest, Big Y, Amish Farms, more||Products containing sunflower kernels||Listeria monocytogenes||Hickory Harvest Foods|
|05/19/2016||Southern Grove, Naturally Select, more||Sunflower seeds, kernels, trail mix products||Listeria monocytogenes||TreeHouse Foods, Inc.|
|05/19/2016||The Caramel Factory||Candies, chocolates and baked goods||Undeclared milk, eggs, peanuts, tree nuts, soy, and/or wheat||The Caramel Factory, LLC|
|05/18/2016||Sunrich Naturals and Planters||Sunflower kernel products||Listeria monocytogenes||SunOpta|
|05/18/2016||Amino Gold||Supplements||Undeclared milk||Ultimate Nutrition|
|05/17/2016||Well Care Compounding Pharmacy||Unexpired sterile compounded products||Concern over lack of sterility assurance||Well Care Compounding Pharmacy|
|05/17/2016||Birdy||Coffee mix (Robusta)||Undeclared milk||Food Gusto Inc.|
|05/17/2016||Tai Pei, Trader Joe’s, Hy-Vee, more||Frozen foods||Listeria monocytogenes, CRF2016||Ajinomoto Windsor, Inc.|
|05/16/2016||Quaker||Quinoa granola bars||Listeria monocytogenes||The Quaker Oats Company|
|05/16/2016||Stahlbush||IQF Green Beans||Listeria monocytogenes||Stahlbush Island Farms, Inc.|
FDA Warning Letters as of 5/25/16
|May 18, 2016||khahan LLC||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Section 301(tt) Violation||Not Issued *|
|May 16, 2016||BBT Biotech Gmbh||Center for Drug Evaluation and Research||CGMP/Active Pharmaceutical Ingredient (API)/Adulterated||Not Issued *|
|May 16, 2016||David Bridgewater||Cincinnati District Office||New Animal Drug/Adulterated||Not Issued *|
|May 16, 2016||N.A. Sales Company Inc.||San Francisco District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|May 16, 2016||Qiagen Sciences LLC||Baltimore District Office||CGMP/QSR/Medical Devices/Adulterated/Misbranded||Not Issued *|
|May 13, 2016||Rocky Fork Formulas Inc||Cincinnati District Office||CGMP/Dietary Supplement/Adulterated/Misbranded||Not Issued *|
|May 12, 2016||Hannibal Company Inc||Cincinnati District Office||CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated||Not Issued *|
|May 12, 2016||Somnowell, Inc.||New Orleans District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|May 12, 2016||Tai Heng Industry Co., Ltd.||Center for Drug Evaluation and Research||CGMP/Active Pharmaceutical Ingredient (API)/Adulterated||Not Issued *|
|May 05, 2016||Banner Pharmacy Services, LLC||Los Angeles District Office||CGMP/Compounded Drugs/Misbranding||Not Issued *|
|May 05, 2016||Renovis Surgical Technologies, Inc.||Los Angeles District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|May 05, 2016||www.baracoatobacconist.com||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded||Not Issued *|
|February 05, 2016||Beauty & Health International Inc.||Los Angeles District Office||CGMP/Dietary Supplement/Adulterated/Misbranded||Not Issued *|
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