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FDA Warning Letter to Nu Skin Enterprises for Drug Listing Violations

The FDA issued a warning letter to Nu Skin Enterprises for violations related to drug listing obligations under the Federal Food, Drug, and Cosmetic Act. The company failed to update manufacturing establishment information and has 61 inactivated drug listings. The FDA requires corrective action within 15 working days.

FDA Warning Letter to Raw Bistro Inc. for CGMP Violations

The FDA issued a warning letter to Raw Bistro Inc. for violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. The facility's product was found to be adulterated due to the presence of Salmonella, leading to a Class I recall.

FDA Warning Letter to Exactech Inc. dba Advita Ortho

The FDA issued a Warning Letter to Exactech, Inc. dba Advita Ortho on December 19, 2025, citing violations of the Quality System Regulation (21 CFR Part 820) during an inspection of their Sarasota, Florida facility. The letter details failures in process control procedures for manufacturing medical devices, specifically the Equinoxe Reverse Shoulder Compression Screw and related accessories.

FDA Warning Letter to SSS AUSTAR LLC for Tobacco Products

The FDA issued a warning letter to SSS AUSTAR LLC for illegally marketing nicotine pouch products without required premarket authorization. The company's product, ZIMO MINT 6MG, is considered adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to snushaven.com for Nicotine Pouches

The FDA issued a warning letter to snushaven.com for selling misbranded nicotine pouches, specifically for selling to individuals under 21. The company is required to take prompt action to address violations of the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to Simtra BioPharma Solutions

The FDA issued a warning letter to Simtra BioPharma Solutions on March 3, 2026, citing significant violations of Current Good Manufacturing Practice (CGMP) regulations at their German drug manufacturing facility. The violations relate to inadequate controls in aseptic processing areas, leading to potential adulteration of drug products intended for the U.S. market.

BaFin Warns High Performance Battery Holding AG of Suspected Public Offer

Germany's financial regulator, BaFin, has issued a warning regarding High Performance Battery Holding AG for suspected public offering of shares without a required prospectus. BaFin suspects the company is offering securities in Germany without the necessary prospectus approval, and no exemptions appear to apply.

FCA Imposes Restrictions on Sendsii Ltd

The FCA has imposed restrictions on Sendsii Ltd, preventing it from carrying out any regulated activity. This action follows the suspension of the firm's registration by HMRC. Sendsii Ltd is required to return all customer funds.

FCA Enforcement: Man jailed for illegal sale-rent-back scheme

The FCA has announced that Rajinder Gill has been sentenced to two and a half years in prison for running an illegal sale-and-rent-back scheme without authorization and illegally providing credit. His accomplices also received sentences. The scheme targeted vulnerable homeowners, resulting in significant financial losses and evictions.

State AGs Sue Trump Administration Over College Data Demand

Massachusetts and 16 other State Attorneys General are suing the Trump Administration to halt new data reporting requirements for colleges and universities. The coalition argues the demand, related to the Supreme Court's affirmative action decision, jeopardizes student privacy and could lead to baseless investigations and penalties.