FDA Links 124 Potential Deaths to Recalled Philips Sleep Aid Devices 
- According to NBCChicago.com, a representative for Philips Respironics stated that the company is examining all claims of fatalities or injuries related to their products. Philips Respironics is involved in a massive global sleep aid device recall, leaving many sleep apnea sufferers without a replacement, and is now being scrutinized by federal authorities in several ways. […]
- According to NBCChicago.com, a representative for Philips Respironics stated that the company is examining all claims of fatalities or injuries related to their products. Philips Respironics is involved in a massive global sleep aid device recall, leaving many sleep apnea sufferers without a replacement, and is now being scrutinized by federal authorities in several ways. […]Instant Pot Pressure Cooker Burn Injury Lawsuit Lawyers - A federal lawsuit has been filed against Instant Brands by an Alabama woman who claims to have suffered disfigurement after using its Instant Pot pressure cooker. The lawsuit, filed on March 14, 2023, in federal court in Alabama, alleges that the woman would use the Instant Pot to prepare family meals until one day, “scalding hot” food […]
- A federal lawsuit has been filed against Instant Brands by an Alabama woman who claims to have suffered disfigurement after using its Instant Pot pressure cooker. The lawsuit, filed on March 14, 2023, in federal court in Alabama, alleges that the woman would use the Instant Pot to prepare family meals until one day, “scalding hot” food […]The Full List of Potentially Bacteria-Contaminated Eye Drops - Several eye drop brands have issued recalls as health officials investigate a severe bacterial outbreak that has been linked to blindness, eye loss, and three deaths. Federal health investigators are learning more about an outbreak of Pseudomonas aeruginosa, an uncommon strain of bacteria that are increasingly being linked to eye drops. This bacterium can cause […]
- Several eye drop brands have issued recalls as health officials investigate a severe bacterial outbreak that has been linked to blindness, eye loss, and three deaths. Federal health investigators are learning more about an outbreak of Pseudomonas aeruginosa, an uncommon strain of bacteria that are increasingly being linked to eye drops. This bacterium can cause […]Lawsuit Claims Gain Laundry Detergent Contains “Likely Human Carcinogen” - Laundry might be tedious, but nothing beats the comfort of fresh sheets or a warm sweatshirt straight from the dryer. You may have a go-to detergent brand, one used by your family, or a new scent you prefer. However, if you’re a regular user of Gain products, take note: a recent lawsuit alleges the detergent […]
- Laundry might be tedious, but nothing beats the comfort of fresh sheets or a warm sweatshirt straight from the dryer. You may have a go-to detergent brand, one used by your family, or a new scent you prefer. However, if you’re a regular user of Gain products, take note: a recent lawsuit alleges the detergent […]E. Coli Contamination Prompts Beef Recall in MD and 8 Other States - The USDA has announced a recall of boneless beef chuck distributed to Maryland and eight additional states due to E. coli contamination. As of March 27, 2023, boneless beef chuck distributed to Maryland and eight other states is being recalled due to E. coli contamination, as stated by the USDA. Elkhorn Valley Packing in Harper, Kansas, […]
- The USDA has announced a recall of boneless beef chuck distributed to Maryland and eight additional states due to E. coli contamination. As of March 27, 2023, boneless beef chuck distributed to Maryland and eight other states is being recalled due to E. coli contamination, as stated by the USDA. Elkhorn Valley Packing in Harper, Kansas, […]What is an FDA Warning Letter? - The U.S. Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by ensuring the efficacy, safety, and security of medical devices, drugs, and other products under its jurisdiction. One of the ways the FDA enforces compliance with regulations is by issuing warning letters to companies that violate established rules or […]
- The U.S. Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by ensuring the efficacy, safety, and security of medical devices, drugs, and other products under its jurisdiction. One of the ways the FDA enforces compliance with regulations is by issuing warning letters to companies that violate established rules or […]FDA Highlights Issues with Next-Generation Olympus Duodenoscopes - Despite the government’s demand to create more “single-use” medical devices, the United States Food and Drug Administration (FDA) is discovering the dangers of single-use devices for use in healthcare. For example, the next-generation Olympus Duodenoscope components seemed to be an innovative safety solution, but recent FDA findings suggest otherwise. Olympus Medical Systems, a leading duodenoscope […]
- Despite the government’s demand to create more “single-use” medical devices, the United States Food and Drug Administration (FDA) is discovering the dangers of single-use devices for use in healthcare. For example, the next-generation Olympus Duodenoscope components seemed to be an innovative safety solution, but recent FDA findings suggest otherwise. Olympus Medical Systems, a leading duodenoscope […]Understanding 501(a)(2)(B) of the FD&C Act: Ensuring Drug Safety and Quality - The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a comprehensive law enacted in 1938 to protect public health by ensuring the safety, security, and efficacy of drugs, biological products, medical devices, cosmetics, and the nation’s food supply. Section 501(a)(2)(B) of the FD&C Act specifically focuses on the requirements for drug manufacturing, ensuring that drugs meet the appropriate […]
- The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a comprehensive law enacted in 1938 to protect public health by ensuring the safety, security, and efficacy of drugs, biological products, medical devices, cosmetics, and the nation’s food supply. Section 501(a)(2)(B) of the FD&C Act specifically focuses on the requirements for drug manufacturing, ensuring that drugs meet the appropriate […]Formology Lab Inc. and Cosmetic Science Laboratories LLC Receive FDA Warning Letters - Cosmetic Science Laboratories LLC in Torrance, CA, and Formology Lab Inc. in Chatsworth, CA, have been issued Warning Letters by the United States Food & Drug Administration (FDA) for substantial violations of Current Good Manufacturing Practice (CGMP) regulations for all finished pharmaceuticals. The FDA cited insufficient detail or evidence of corrective actions in the response […]
- Cosmetic Science Laboratories LLC in Torrance, CA, and Formology Lab Inc. in Chatsworth, CA, have been issued Warning Letters by the United States Food & Drug Administration (FDA) for substantial violations of Current Good Manufacturing Practice (CGMP) regulations for all finished pharmaceuticals. The FDA cited insufficient detail or evidence of corrective actions in the response […]FDA Laboratory Warning Letters - The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety and efficacy of pharmaceuticals, medical devices, and other regulated products. FDA inspections are a crucial part of this process, as they help the agency identify and address compliance issues within regulated organizations. Laboratory facilities are subject to FDA inspections, and […]
- The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety and efficacy of pharmaceuticals, medical devices, and other regulated products. FDA inspections are a crucial part of this process, as they help the agency identify and address compliance issues within regulated organizations. Laboratory facilities are subject to FDA inspections, and […]
