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.

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.

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.

Mother's Parental Rights Termination Affirmed

The Tennessee Court of Appeals affirmed a trial court's decision to terminate a mother's parental rights due to abandonment and severe abuse. The mother's appeal was unsuccessful, and the case was remanded.

M.C. v. United States of America - Civil Case Filing

A new civil case, M.C. v. United States of America (Federal Bureau of Prisons) et al, was filed on March 11, 2026, in the U.S. District Court for the Northern District of California. The case involves a complaint against the U.S. Government and includes filings for proposed summons and a motion to maintain plaintiff anonymity.

Andrew Dill v. Southcoast Visiting Nurse Association, Inc. - Vaccine Retaliation Claim Dismissed

The District Court of Massachusetts dismissed Andrew Dill's vaccine retaliation claim against his former employer, Southcoast Visiting Nurse Association, Inc. The court granted the defendant's motion to dismiss the complaint.

Strike 3 Holdings, LLC v. John Doe - IP Address Subpoena

The District Court of Massachusetts granted Strike 3 Holdings, LLC leave to serve a third-party subpoena on an ISP to identify a John Doe defendant accused of copyright infringement. The court found the discovery warranted prior to a Rule 26(f) conference to allow for service of process.

Strike 3 Holdings LLC v. John Doe - Subpoena for Identity

The U.S. District Court for Massachusetts granted Strike 3 Holdings, LLC's motion to serve a third-party subpoena on an ISP before a Rule 26(f) conference. This allows Strike 3 to identify an unknown defendant, John Doe, allegedly involved in copyright infringement of adult films.

Nuclear Regulatory Commission: Streamlining Contested Adjudications in Licensing Proceedings

The Nuclear Regulatory Commission has published a proposed rule to streamline contested adjudications in licensing proceedings. The rule aims to improve the efficiency of these proceedings and includes provisions for a public meeting.

Attorney General Criticizes Rate Increase for Yankee Gas

Connecticut Attorney General William Tong criticized the Public Utilities Regulatory Authority (PURA) for approving an additional $4 million rate increase for Eversource-owned Yankee Gas. This decision follows previous rate hikes and penalty eliminations for other utility companies, drawing strong condemnation from the AG regarding the impact on consumers.