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FORM 483 OBSERVATIONS
Warren Buffett on how CEOs manipulate earnings – and how to spot itWarren Buffett compared modern corporate accounting to a golfer who turns in a score of 140 in his first round (thanks to fake bogeys), and...- 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...
- USFDA issues Form-483 with 5 observations to Ajanta Pharma's Paithan facilityAjanta Pharma said the US FDA has issued Form-483 with five observations after inspecting its Paithan manufacturing facility in Maharashtra...
- USFDA issues Form 483 with 3 observations to Ipca's Tarapur plantAs per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any con...
- USFDA issues Form 483 with 7 observations to Natco's pharma Hyderabad divisionNatco Pharma announced that its Hyderabad-based pharma division received a Form 483 with seven observations from the USFDA following an ins...
- Sun Pharma gets eight observations from USFDA for Halol plantSun Pharma announced that the USFDA issued a Form 483 with eight observations after inspecting its Halol manufacturing plant in Gujarat. Th...
- USFDA issues Form 483 with 11 observations to Raleigh plant of Aurobindo Pharma armAurobindo Pharma Ltd announced that the USFDA issued a Form 483 with 11 observations following an inspection of its Aurolife Pharma LLC's R...
- USFDA issues Form 483 with 3 three observations to Gland Pharma's Visakhapatnam unitGland Pharma Ltd's facility at Visakhapatnam received three Form 483 observations from the USFDA after a recent inspection for sterile APIs...
- Cipla shares in focus after Goa facility receives form 483 with one observation from USFDACipla share price has risen by 10% over the past 12 months and 64% over the last three years. The company's current market capitalization i...
- Biocon arm's growth formula: US rollouts & debt reductionBiocon Biologics planned to introduce six new biosimilar products in the US in the next two years, subject to regulatory approval. They emp...
- USFDA issues Form 483 with five observations to Torrent Pharma unitTorrent Pharmaceuticals announced that the US Food and Drug Administration (USFDA) issued a Form 483 with five observations after inspectin...
- USFDA issues Form-483 with two observations for Lupin's Nagpur plantLupin's Nagpur facility has received two observations from the USFDA through Form-483 due to violations of the Food Drug and Cosmetic (FD&C...
- USFDA issues Form-483 with 8 observations to Lupin's drug, API production facilities in Mandideep plantThe USFDA had inspected the Mandideep Unit-1 facility in Madhya Pradesh from November 14, 2022, to November 23, 2022, the Mumbai-based drug...
- Alembic Pharma receives 4 observations from USFDA for Panelav facility"The US Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals general oral solid formulation facility...
- Strides Pharma drops 3% on USFDA observation for Bengaluru plantThe observations are not material in nature, the company said.
- Strides Shasun gets 3 observations from USFDA for Bangalore plant"The formulations facility in Bangalore was recently inspected by the US FDA. The company has been issued a Form 483 with 3 observations," ...
- Lupin gets three observations from USFDA for Goa plantAs per the USFDA, observations are made in Form 483 when investigators feel that practices in the facility are such that products may becom...
- USFDA made 9 observations post Halol unit inspection: Sun PharmaThe United States Food and Drug Administration (USFDA) inspected the Halol facility from November 17, 2016 through December 1, 2016, Sun Ph...
- FDA issues observations post Sun Pharma Halol plant inspectionThe approval of several of Sun's key drugs in the United States, the drugmaker's biggest market, depends on the clearance on its Halol plan...
- Credit Suisse downgrades Ipca Labs; stock plunges 15%Credit Suisse is of the view that there are 6 observations on Indore SEZ in Form 483 out of which 2 are critical observations.
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