Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, February 2, 2023
Wednesday, February 1, 2023
Adept Life Science, LLC | Division of Human and Animal Food Operations East IV | CGMP/Dietary Supplement/Misbranded |
Noble Elements, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
Organic Heirloom Plants | Center for Food Safety and Applied Nutrition (CFSAN) | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
Dr. Green Mom, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
RightEye, LLC | Division of Medical Device and Radiological Health Operations East | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||
Urban Electric Power | Division of Pharmaceutical Quality Operations I | CGMP/Drug Products/Adulterated | |||
Mohawk Laboratories Division of NCH Corporation | Division of Pharmaceutical Quality Operations II | CGMP/Drug Products/Adulterated | |||
Old Tiles Wallpaper, LLC DBA Old Tiles Decor | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
Monkeypox-treatment.com | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
S&S Quality Wholesale Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||
Shenzhen GreenSound High-Tech Co., LTD d/b/a Vaporlax | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
llegally Sold Monkeypox (Mpox) Products
The U.S. Food and Drug Administration (FDA) issued warnings to companies illegally selling products that claim to cure, treat, mitigate, or prevent human monkeypox (mpox) infection. Mpox is a rare disease that is caused by infection with mpox virus. This virus can spread to anyone through close, personal, often skin-to-skin contact. There are no FDA-approved treatments for mpox. These products, which are often sold online, have not been reviewed by the FDA or proven to be safe and effective to treat mpox or other diseases or conditions. These products may be ineffective, unsafe, and could prevent a person from seeking an appropriate diagnosis and treatment from a health care professional. |
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Monday, January 30, 2023
"Today, the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction against LGM Pharma LLC, an importer and distributor of active pharmaceutical ingredients (API), used by the company’s customers to manufacture and/or compound finished drug products,...."
Federal Court Enters Consent Decree Against Florida-based Drug Importer and Distributor
Today, the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction against LGM Pharma LLC, an importer and distributor of active pharmaceutical ingredients (API), used by the company’s customers to manufacture and/or compound finished drug products, and two of the company’s executives, Chief Executive Officer and part owner, Prasad Raje, and Shailesh Vengurlekar, the company’s Senior Vice President of Quality and Regulatory Affairs.
The consent decree sets a strict timetable and requirements for the firm to ensure it obtains compliance with current good manufacturing practice (CGMP) requirements under the Federal Food, Drug, and Cosmetics Act (FD&C Act). Among other things, the consent decree requires ongoing compliance auditing and reporting to the U.S. Food and Drug Administration and also provides that the FDA may take appropriate action, including ordering the company to cease receiving, labeling, holding and/or distributing any or all drug substances, in the event the defendants further violate the FD&C Act, its implementing regulations or the consent decree.
According to the complaint filed by the U.S. Department of Justice on behalf of the FDA, LGM Pharma LLC introduced into interstate commerce adulterated drugs that were manufactured, processed, packed or held in conditions that do not comply with CGMP requirements under the FD&C Act.
“Protecting patients means we must hold all parts of our drug supply chain to the highest standards of quality allowed by law, including importers and distributors of both finished drug products and active pharmaceutical ingredients,” said Jill P. Furman, J.D., acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “LGM Pharma LLC’s failure to adhere to CGMP requirements put patients at risk. This consent decree requires the firm to implement and adhere to rigorous quality standards, under close FDA supervision. We will continue to do everything in our power to ensure compliance and address violations of federal law to protect the American public and the safety of the drug products they rely on.”
The agency inspected the company’s Florida and Kentucky facilities in 2022. During these inspections, the FDA identified significant departures from CGMP requirements, including the company’s failure to perform adequate investigations of quality-related customer complaints involving out-of-specification (OOS) API that it distributed, failure to adequately qualify foreign manufacturers of API imported and distributed by the company and failures to establish adequate procedures for the distribution of drugs after an API supplier has been disqualified by the company. A previous inspection of LGM Pharma LLC’s Kentucky facility also revealed significant non-compliance with CGMP requirements, including the company’s improper re-labeling of API, lack of sufficient qualification procedures for the company’s foreign API suppliers and failure to perform adequate investigations of quality-related customer complaints involving OOS API distributed by the company.
Today’s action will require the company to undertake detailed quality-related compliance actions to ensure that the company’s processes for importing and distributing drugs conform to CGMP requirements and federal law.
The case was filed by the U.S. Department of Justice’s Consumer Protection Branch, on behalf of the FDA.
Thursday, January 26, 2023
Cloud Dreams, Inc. dba Rx Vape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
Sabrina Cosmetics d/b/a SCOS | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
New Vaping US | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding | Division of Pharmaceutical Quality Operations II | Compounding Pharmacy/Adulterated Drug Products | ||||
Lineage Vapors LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
Larkin Community Hospital Institutional Review Board | Center for Drug Evaluation and Research | CDER | Bioresearch Monitoring Program/Institutional Review Board (IRB) | ||||
Evimeria El Aztecano, Inc. | Division of Human and Animal Food Operations West V | Dietary Supplement/Misbranded | ||||
Buzzagogo, LLC | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | ||||
Leimax, Corp. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
Fuentes Farms LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
Tuesday, January 24, 2023
Friday, January 20, 2023
- Today, the FDA issued an immediately-in-effect guidance on compounding certain ibuprofen products in an effort to bolster supply of pediatric ibuprofen amid record high demand. The guidance clarifies FDA’s regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems.