FDA

Go Raw LLC Expands Cat Food Recall for Low Thiamine Levels

Go Raw LLC is expanding its voluntary recall of Quest Cat Food Chicken Recipe products due to low thiamine levels. The company is also stopping the sale of all Quest products until the issue is resolved. The expanded recall affects products distributed nationwide.

FDA Warning Letter to MedisourceRx

The FDA issued a warning letter to MedisourceRx on December 12, 2025, for failing to meet the conditions of section 503B of the FDCA. The inspection revealed that the outsourcing facility did not submit adverse event reports as required, violating federal drug laws.

FDA Warning Letter to East CK Trading Inc.

The FDA issued a warning letter to East CK Trading Inc. for significant violations of the Foreign Supplier Verification Program (FSVP) regulation. The company failed to develop and maintain an FSVP for imported foods, leading to potential refusal of admission and detention without physical examination.

FDA Warning Letter to Dynamic Stem Cell Therapy

The FDA issued a warning letter to Dynamic Stem Cell Therapy for misbranding an umbilical cord-derived stem cell product. The product is considered an unapproved new drug and an unlicensed biological product, violating the Federal Food, Drug, and Cosmetic Act. The FDA's review found claims on the company's website indicating the product is intended to diagnose, cure, mitigate, treat, or prevent disease.

FDA Warning Letter to AQ USA Inc. for Drug Manufacturing Violations

The FDA issued a warning letter to AQ USA Inc., d.b.a Ross Healthcare Inc., for significant Current Good Manufacturing Practice (CGMP) violations at its drug manufacturing facility in Lynden, Washington. The violations include inadequate laboratory testing for microbial contamination and failure to establish appropriate specifications for drug products.

FDA Warning Letter to A. Nelson & Co. Ltd

The FDA issued a warning letter to A. Nelson & Co. Ltd. for significant violations of Current Good Manufacturing Practice (CGMP) regulations, including inadequate microbial testing and unsupported expiration date extensions. The company's drug products were found to be adulterated.

FDA Amends Animal Drug Approval and Withdrawal Rules

The Food and Drug Administration (FDA) has amended regulations concerning the approval and withdrawal of new animal drug applications. These changes are effective February 6, 2026, and impact the procedures for drug sponsors and the handling of drug approvals.

FDA Allows Spirulina Extract as Color Additive in Human Foods

The Food and Drug Administration (FDA) has issued a final rule allowing spirulina extract to be used as a color additive in human foods. This rule amends the list of color additives exempt from certification. The comment period for this rule closes on March 9, 2026.

FDA Amends Food Coloring Regulations for Beetroot Red

The Food and Drug Administration (FDA) has amended regulations concerning the use of beetroot red as a food coloring additive. This rule finalizes changes to the listing of color additives exempt from certification, specifically impacting beetroot red.

FDA Revokes Mutual Recognition of EU Pharma and Device Reports

The Food and Drug Administration (FDA) is revoking regulations that allowed for the mutual recognition of pharmaceutical Good Manufacturing Practice (GMP) reports and medical device quality system audit reports with the European Community. This action will impact the oversight and inspection processes for products traded between the US and the EU.