FDA Warning Letter to Yangzhou H&R Plastic Daily Chemical Co., Ltd.

The FDA issued a warning letter to Yangzhou H&R Plastic Daily Chemical Co., Ltd. following an inspection that revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations. The company failed to adequately test drug products for identity and strength before release and did not properly test incoming components.

FDA Warning Letter to 4U Health for Adulterated Biologics

The FDA issued a warning letter to 4U Health for distributing an unapproved HIV serological diagnostic dried blood spot self-collection kit. The kit is considered adulterated and misbranded because it lacks the required premarket approval or investigational device exemption.

FDA Warning Letter to Matesbrand.com for Nicotine Pouches

The FDA issued a warning letter to matesbrand.com for illegally marketing new tobacco products, specifically nicotine pouches, without required premarket authorization. The agency determined that the listed nicotine pouch products are adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to Longhorn Vaccines and Diagnostics LLC

The FDA issued a warning letter to Longhorn Vaccines and Diagnostics LLC regarding violations of the Quality System Regulation for their PrimeStore® MTM device. The inspection revealed that the devices are adulterated due to inadequate complaint file maintenance and failure to establish proper complaint handling procedures, including evaluating complaints for medical device reporting.

FDA Warning Letter to ImmunityBio Inc. Regarding ANKTIVA®

The FDA issued a warning letter to ImmunityBio Inc. concerning promotional communications for its drug ANKTIVA®. The FDA determined that a direct-to-consumer broadcast advertisement and a podcast were false or misleading, misbranding the drug and violating the Federal Food, Drug, and Cosmetic Act. The agency expressed concern that these communications create a misleading impression that ANKTIVA can cure or prevent all cancer.

O'Leary v. Jones - Arbitration Award Confirmation Dismissed

The California Court of Appeal affirmed the trial court's denial of attorney's fees but remanded for the award of court costs to the appellant in O'Leary v. Jones. The case involved the dismissal of a petition to confirm an arbitration award due to lack of personal jurisdiction.

Guardian Storage Centers v. Simpson - Appeal of Disqualification Orders

The California Court of Appeal has reversed disqualification orders in the case of Guardian Storage Centers v. Simpson. The appellate court will review the trial court's application of legal standards concerning an attorney's review of inadvertently transmitted privileged communications belonging to an opposing party.

Pechkis v. Trustees: Anti-SLAPP Denied, Retaliation, Discrimination Ruling

The California Court of Appeal affirmed a trial court's denial of an anti-SLAPP motion brought by the Trustees of the California State University. The ruling concerns retaliation claims filed by professors who reported discrimination and harassment. The court found the defendant failed to demonstrate the claims arose from protected activity.

Massachusetts Extends RSV Immunizations for Infants Through April 30, 2026

The Massachusetts Department of Public Health has extended its recommendation for RSV monoclonal antibody immunizations for eligible infants through April 30, 2026, due to ongoing elevated RSV activity. This advisory urges healthcare providers to continue administering these preventive measures to protect vulnerable infants from severe illness.

AG Uthmeier Secures Sentences for Fentanyl Trafficking

Florida Attorney General James Uthmeier announced the sentencing of Renee and Vincent Stephens to 60 and 30 years in prison, respectively, for fentanyl trafficking in Hillsborough County. The couple operated a drug trafficking scheme, with Vincent directing activities from prison and Renee selling fentanyl from their apartment where a child was present.