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Warning Letter

All articles tagged with #warning letter

business1 month ago•4 min saved

FDA Warns Novo Nordisk Over PADE Reporting at US HQ

The FDA issued a Warning Letter to Novo Nordisk’s Plainsboro, New Jersey US headquarters after a January–February 2025 inspection found deficiencies in postmarketing adverse event surveillance and reporting under PADE, including issues with reporting timing and potential rejection of reports and insufficient root-cause analysis. Novo says it has a corrective action plan, has supplied seven progress updates, and remains confident it will address the regulator’s concerns. The letter follows a Form 483 and sits within broader U.S. regulatory scrutiny that includes other letters related to Ozempic/Wegovy and a Bloomington, Indiana facility, though the FDA states the warning does not judge drug quality or safety.

via Fierce Pharma|

#business #fda #form-483

celebrity1 month ago•38 min saved

Savannah Chrisley Under FDA Scrutiny Over Weight-Loss Drug Claims

Celebrity Savannah Chrisley drew an FDA warning over statements on her GoodGirlRX site implying FDA‑approved weight‑loss drugs, which the FDA said were not FDA‑approved or evaluated for safety. In response, the site was updated to say the results are clinically studied and that the GLP‑1 drugs are not FDA‑approved. The FDA gave 15 business days to make corrections. GoodGirlRX was launched with Verb Technology to offer prescription weight‑loss options for women, a move that continues to keep Chrisley in the media spotlight.

via Yahoo|

#celebrity #fda #goodgirlrx

local-news2 years ago•1 min saved

Sacramento DA Takes Action Against "Toxic" Camp Resolution Following Water Board Investigation

The Sacramento County District Attorney has sent a warning letter to the City of Sacramento and camp advocates regarding the property known as Camp Resolution, claiming it sits on a lot contaminated with toxic chemicals. The letter could potentially lead to criminal charges as part of the ongoing legal fight over the growing homeless crisis. The property, currently operated by Safe Ground Sacramento as a self-governing encampment, was previously used as a vehicle maintenance yard and has been found to have soil pollution from underground gas tanks. The DA's office is required to provide notice and allow the offending parties to address the dangerous condition before filing criminal charges.

via CBS Sacramento|

#camp-resolution #homelessness #local-news

food-safety2 years ago•8 min saved

FDA Issues Warning to Baking Company Over Listeria and Pest Infestation

The Food and Drug Administration (FDA) has issued a warning letter to Schwebel Baking Company, a food firm in Ohio, for serious violations of food safety regulations. The violations include the presence of rodents, flies, and Listeria in their ready-to-eat (RTE) processing facility. The FDA found that the company failed to identify and evaluate hazards related to allergen cross-contact and environmental contamination, and did not implement appropriate preventive controls. The company also did not adequately address sanitation and pest control issues. The FDA's warning letter highlights the need for the company to take immediate corrective actions to ensure compliance with food safety regulations.

via Food Safety News|

#fda #food-safety #schwebel-baking-company