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FORM 483
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...
- China lowers death toll in Shanxi coal mine disaster to 82A devastating gas explosion at the Liushenyu coal mine in China's Shanxi province has claimed 82 lives. This incident marks the nation's de...
- 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...
- Delhi-NCR, Bengaluru office rentals cross Rs 100/sq ft/month milestone: Knight FrankOffice rental rates in Bengaluru and Delhi-NCR have now crossed Rs 100 per sq ft. This milestone is driven by strong demand for prime works...
- 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...
- 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...
- Shilpa Medicare shares hit lower circuit after USFDA observations for Telangana unitThe US Food and Drug Administration (USFDA) issued form 483 with 15 observations to the company’s Jadcherla Unit
- Indoco Remedies receives EIR from USFDAIndoco Remedies got "establishment inspection report (EIR) for its Clinical Research Organisation, AnaCipher, located at Hyderabad for the ...
- USFDA finds several violations in Aurobindo sterile injections unitFDA investigators have observed violations in sterilisation process to prevent microbial contamination and shortcomings in facility managem...
- No data integrity or repeat observations in the Form 483 we received: Kedar Upadhye, CiplaWe are in the process of drafting a very robust response to each of the observations in the Form 483.
- Inspection of Unichem's Kolhapur facility by USFDA completed without observationsThe inspection was a CGMP surveillance and pre-approval inspection and was successfully concluded without any FDA Form 483 issued.
- USFDA concludes inspection of Unichem Lab's Roha facilityThe inspection was a post-approval inspection and successfully concluded.
- Audit of Laurus Labs completed by USFDA without objectionsThe maiden United States Food and Drug Administration (USFDA) audit for Laurus Labs was successfully completed without Form 483 .
- USFDA issues 5 observations to Dr Reddy's plant in HyderabadDr.Reddy's Laboratories was issued a Form 483 which notifies the company's management of objectionable conditions, with 5 observations.
- Aurobindo Pharma drops 5% on USFDA observationsShares of Aurobindo Pharma declined to Rs 605.90.
- Sun Pharma gets 6 observations by USFDA for its Halol facility"At the conclusion of the inspection, the agency issued a Form 483, with six observations," it added.
- USFDA completes inspection at Caplin Point Lab's sterile injectable facility in Tamil Nadu"The United States Food and Drug Administration (USFDA) has conducted an inspection at our sterile injectable site (CP-IV) located at Gummu...
- Received observations from USFDA, responded to all: BioconThe company was responding to reports that the US health regulator has issued observations under Form 483 highlighting issues related to qu...
- 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...
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