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MANUFACTURING ISSUES FDA
Death in a vial: Five cases lay bare many uncomfortable truths about Indian healthcareFive young mothers in Kota died after childbirth, with suspicion falling on oxytocin injections. Investigations revealed the vials containe...- FDA issues compliance order for milk sector in Maharashtra; warns of Rs 10 lakh fine for violationsMaharashtra FDA has mandated strict food safety compliance across the entire milk supply chain, from farms to retailers. New guidelines aim...
- Why CDSCO and BEE have not kept pace with the industries they overseeCDSCO still faces challenges like chronic understaffing, gaps in technical skills, weak lab infra and fragmented approvals. About a decade ...
- Plan in the works to let hospitals import med equipment directlyIndia's drug regulator is proposing to allow hospitals to directly import advanced medical equipment like MRI and CT scanners, bypassing cu...
- USFDA concludes inspection at Jubilant HollisterStier's Spokane plant with 8 observationsJubilant Pharmova announced its US subsidiary, Jubilant HollisterStier LLC, underwent a USFDA inspection. The facility in Spokane, Washingt...
- FDA expands recall to all Clover Hill Dairy cheeses after listeria found in products and facilityUS food safety authorities have expanded a cheese recall due to Listeria contamination, now encompassing all products from Clover Hill Dair...
- Over 58,000 cases of Aldi's Park Street Deli macaroni & cheese recalled nationwide due to undeclared soyAldi's popular Park Street Deli Macaroni & Cheese is under recall for undeclared soy. BEF Foods, Inc. has pulled over 58,000 cases nationwi...
- Alfredo sauce recall: Product sold in 41 US states gets FDA's highest-risk warning over possible Salmonella contaminationAlfredo sauce recall is underway across 41 states. The US Food and Drug Administration has classified this as a Class I recall, its most se...
- Dabur India shares in focus after US FDA places drugs from Silvassa plant under import alert. Here’s whyDabur India shares are set to be in focus after the US FDA issued an import alert on drugs manufactured at its Silvassa plant, citing data ...
- US drug regulator issues import alert for drugs made at a Dabur India plantThe US Food and Drug Administration has placed Dabur India's factory on an import alert. This action follows an inspection that revealed si...
- No raids till further orders: Maharashtra tells Bombay HC in Patanjali labelling caseThe Maharashtra government has assured the Bombay High Court it will halt raids and confiscations concerning ayurvedic product labels. This...
- More macro headwinds on the cards? Tackle them with core principles: 6 pharma stocks with upside potential of up to 28%There was a time when the Indian pharma story in the US was almost entirely about inspection risk. The US FDA would inspect a plant, a warn...
- U.S. drug regulator flags data integrity, maintenance lapses at Dabur India plantThe U.S. FDA has identified significant data integrity and manufacturing lapses at a Dabur India plant following a January inspection. Find...
- Pregabalin moved to Schedule H1 as centre cracks down on drug misusePregabalin, a nerve pain medication, now faces stricter controls. The Union health ministry has moved it to Schedule H1. This change aims t...
- Fake mango alert: 3,800 kg of chemically made pulp seized in Pune. Know side effects & how to identify artificially ripened aam at homeMango Adulteration Alert: With the mango season in full swing, rising cases of mango adulteration in India have sparked serious food safety...
- Drugmaker Granules to tighten oversight after US FDA warning, executive saysThe company, which is globally one of the largest paracetamol makers and a major player in the active pharmaceutical ingredients market, de...
- Indian drugmaker Granules to tighten oversight after US FDA warning, exec saysAmid growing scrutiny from the U.S. FDA over documentation practices and contamination issues, Granules India is reinforcing its manufactur...
- US FDA issues import alert to 2 plants of IPCA LaboratoriesThe U.S. regulator had in January banned imports from a separate central Indian manufacturing plant of Ipca, citing violations of standard ...
- USFDA clears Cipla's facilitiesCipla has successfully addressed all the nine manufacturing deficiencies pointed out by the US Food and Drug Administration (FDA) at its Ba...
- Lupin’s MP plant under USFDA scannerThe US Food and Drug Administration (USFDA) has found 15 manufacturing deficiencies at one of Lupin’s plant in Madhya Pradesh (MP) during t...
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