FDA Warning Letters

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.

FDA Warning Letter to Good Girl LLC for False Claims

The FDA issued a warning letter to Good Girl LLC (dba GoodGirlRX) for making false and misleading claims on its website regarding compounded semaglutide and tirzepatide products. The company claimed the products were 'FDA-approved' and that GoodGirl RX was the compounder, which the FDA states is false and misbrands the drugs.

FDA Warning Letter to Lean Rx Inc. dba SkinnyRx

The FDA issued a warning letter to Lean Rx Inc. dba SkinnyRx for misbranding compounded semaglutide and tirzepatide products. The agency cited false or misleading claims on the company's website regarding the compounding of these drugs and their relation to FDA-approved medications.

FDA Warning Letter to PharmaZee for False Claims

The FDA issued a warning letter to PharmaZee for making false and misleading claims on its website regarding compounded semaglutide and tirzepatide products. The agency found that PharmaZee misrepresented itself as the compounder and implied FDA approval for these unapproved drugs, violating the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to Refills Health for False Claims

The FDA issued a warning letter to Refills Health, LLC for making false and misleading claims on its website regarding compounded semaglutide products. The agency found that the company misrepresented itself as the compounder and made unsubstantiated claims such as 'clinically proven,' leading to the products being considered misbranded under the FDCA.

FDA Warning Letter to Peaks Curative for False Claims

The FDA issued a warning letter to Peaks Curative, LLC for making false and misleading claims on its website regarding compounded semaglutide products. The agency found that the company misrepresented its compounding practices and implied FDA approval for products that are not FDA-approved, leading to misbranding violations.

FDA Warning Letter to Ivim Services LLC for Misbranded Drugs

The FDA issued a warning letter to Ivim Services LLC for introducing misbranded compounded semaglutide and tirzepatide products into interstate commerce. The agency found that Ivim's website made false or misleading claims, suggesting Ivim was the compounder when it was not, violating the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to Premium Health Management

The FDA issued a warning letter to Premium Health Management Inc. for misbranding compounded semaglutide and tirzepatide products. The company's website made false or misleading claims about the products, suggesting they were compounded by Premium Health when they were not, and implying FDA approval or evaluation.

FDA Warning Letter to Las Americas Supermercado#2 Inc.

The FDA issued a warning letter to Las Americas Supermercado#2 Inc. for significant violations of the Foreign Supplier Verification Program (FSVP) regulation. The inspection revealed the company failed to develop and maintain an FSVP for imported foods, a violation of the Federal Food, Drug, and Cosmetic Act.