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FDA INSPECTION OBSERVATIONS
USFDA ends inspection of Aurobindo Pharma arm's facility with 4 observationsAurobindo Pharma announced its subsidiary Lannett Company LLC's facility inspection concluded. The US Food and Drug Administration conducte...- Indian food safety officer Tukaram Mundhe shakes up Mumbai, one viral raid at a timeTukaram Mundhe is leading an unprecedented food safety crackdown across Mumbai. His teams have conducted over 3,000 raids, inspecting numer...
- Stocks in news: Reliance Industries, Bank of Baroda, Power Grid, NATCO Pharma and JSW InfraIndian equity markets closed largely unchanged on Friday, August 21, after a volatile trading session. Several companies, including Relianc...
- Strides Pharma Science shares jump 9% after USFDA EIR for Bengaluru facilityStrides Pharma Science shares rise sharply on Thursday after the USFDA issued an Establishment Inspection Report (EIR) for its Bengaluru fa...
- Pune sweets shop wins ₹5 lakh after food licence stays suspended despite 98% complianceThe Bombay High Court criticized the Maharashtra FDA for its actions. The court ordered the FDA to pay Rs 5 lakh compensation to a sweets s...
- Aurobindo Pharma’s Raleigh plant gets 'Voluntary Action Indicated' classification from US FDAAurobindo Pharma's US facility received a Voluntary Action Indicated classification. The US FDA closed its inspection of the Raleigh manufa...
- ETtech Explainer: Why are dark stores again under scrutiny over food safetyFood safety inspectors have conducted thorough checks on quick commerce locations in Karnataka and Maharashtra, revealing violations relate...
- Aurobindo Pharma arm Eugia Pharma's Telangana unit gets warning letter from USFDAAurobindo Pharma announced its subsidiary Eugia Pharma received a USFDA warning letter. This follows an inspection of their Telangana formu...
- Zepto warehouse sealed in Bengaluru over food safety violationsBengaluru authorities sealed a Zepto warehouse for hygiene and labeling violations. The Food Safety Department conducted inspections follow...
- Picking the right pharma stock is getting harder; so pick a portfolio: 20 stocks with -23% to +22% downside to upside potentialFor Indian pharma, the regulatory risk is still real. A US FDA inspection can still cause trouble. A plant making an important product or g...
- Kitchen checks give restaurants, hotels food for thoughtRestaurants nationwide are voluntarily closing outlets for deep cleaning and hygiene improvements. Regulatory crackdowns over food safety a...
- Bombay HC restores FDA-suspended Navi Mumbai hotel's licence, says 'we are in India, need a realistic approach'The Bombay High Court quashed an FDA order suspending a hotel's food license. This action followed a surprise inspection which found only t...
- 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...
- Punjab drug body finds critical lapses at Jackson Laboratories' manufacturing facility in AmritsarThe Punjab FDA has taken decisive action by revoking the manufacturing licence of Jackson Laboratories in Amritsar due to severe regulatory...
- 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...
- Maharashtra FDA bars hospitals from forcing patients to buy medicines in-houseMaharashtra's Food and Drug Administration has issued a significant directive. Hospitals and medical practitioners must now allow patients ...
- 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 ...
- Understanding US FDA inspection: How investors and management can avoid heartburnWith India playing a significant role in the global pharmaceutical sector, one may wonder about the quality control practices adopted in th...
- Documents potentially misleading in Aurobindo Pharma's Unit-VII: USFDAThe FDA conducted a cGMP (Current Good Manufacturing Practices) inspection at the Unit 7 manufacturing facility from September 19-27 this y...
- 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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