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ROUTINE FDA INSPECTION
Biocon shares rise 2% after USFDA concludes inspection with 5 observationsBiocon shares: The inspection, carried out from August 26 to September 3, 2025, spanned multiple operational areas such as drug substance m...05 Sep, 2025, 10.30 AM IST- No observations by US FDA during plant inspection: DRLDr. Reddy's Laboratories announced that the U.S. Food & Drug Administration (FDA) completed a routine Good Manufacturing Practice (GMP) ins...21 Sep, 2024, 12.14 AM IST
- Torrent Pharma gets an observation from USFDA for Pithampur plantTorrent Pharmaceuticals announced that the USFDA issued a Form 483 with one procedural observation after inspecting its Pithampur manufactu...20 Sep, 2024, 02.47 PM IST
- US lawmaker seeks answers on FDA inspection of Musk's NeuralinkNeuralink, which first tested its device in monkeys and other animals, is now testing the device in humans. The company makes a brain-chip ...26 Mar, 2024, 09.19 PM IST
- Elon Musk's Neuralink cited by FDA over animal lab issuesThe inspectors identified quality control lapses at the company's California animal research facility. A similar inspection at Neuralink's ...29 Feb, 2024, 11.04 PM IST
- USFDA issues Form-483 with 3 observations to Alkem Lab's St Louis plant"There is no data integrity observation. This pre-Approval Inspection is part of the routine business operations and the company shall subm...10 Nov, 2022, 09.34 PM IST
- USFDA Looks for Ways to Speed up Plant InspectionsThe move has been triggered by the shortage of drugs — most of them supplied by Indian generic drug companies — that the US faces during th...16 May, 2020, 09.28 AM IST
- USFDA inspection of Unichem Lab's Roha facility completed with no observationDrug firm Unichem Laboratories on Monday said the US health regulator has completed inspection of its Roha facility in Maharashtra without ...24 Feb, 2020, 05.21 PM IST
- USFDA inspection was planned and company was informed in advance: Sucheth Rao Davuluri, Neuland LabsIn an exclusive chat with ET Now, Sucheth Rao Davuluri, VC & CEO, Neuland Labs, said that the firm has already started working on clearing ...11 Apr, 2017, 11.53 AM IST
- Sun Pharma Halol site being inspected by US FDA: SourcesOver its recent call with investors, Sun Pharma management had maintained that the remediation exercise at the site have been completed and...18 Nov, 2016, 09.56 AM IST
- UP Food safety officials raid Vishal Mega Mart, seize productsDuring the inspection, the team found that 20 packets of a sweet dish. A video of the items was also taken by FDA team as evidence.24 Jul, 2015, 11.32 PM IST
- India wants its officials during USFDA inspections at drug unitsIn many cases, these companies have been barred from selling their drugs in the US and other countries, although Indian firms account for a...11 Jan, 2015, 12.19 PM IST
- Gujarat FDA recalls batch of diarrhea drug LoproGujarat FDA has stopped the sale of diarrhoea tablet Lopro, made by Danish Laboratories, after terming the drug sub-standard.31 May, 2012, 08.20 PM IST
- 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...31 Aug, 2009, 12.34 AM IST
- After Ranbaxy, FDA finds gaps at CiplaThe US Food and Drug Administration (FDA) has found nine deviations in Indian drug maker Cipla’s manufacturing process during a recent insp...20 Apr, 2009, 12.02 AM IST
- 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...14 Nov, 2008, 12.00 AM IST
- US to broaden scrutiny of drug facilities in China, IndiaFaced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in countries l...10 Jul, 2008, 03.07 AM IST
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