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FDA INSPECTION OBSERVATIONS
Maharashtra FDA bars hospitals from forcing patients to buy medicines in-house- Dabur India shares in focus after US FDA places drugs from Silvassa plant under import alert. Here’s why
- More macro headwinds on the cards? Tackle them with core principles: 6 pharma stocks with upside potential of up to 28%
- 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...29 May, 2026, 12.30 PM IST
- Compliance squeeze, global scrutiny redefine India’s $30 billion pharma export playbookAs global markets prioritise quality and regulatory trust, India’s pharma sector is recalibrating beyond its traditional cost advantage.01 May, 2026, 11.26 AM IST
- USFDA issues Form 483 with 8 observations to Aurobindo's Telangana unitAurobindo Pharma faces scrutiny. The US FDA inspected its Bachupally, Telangana plant. The inspection occurred between August 25 and Septem...05 Sep, 2025, 08.29 PM IST
- US FDA inspects Vishakhapatnam facility of Solara Active PharmaThe US Food and Drug Administration (FDA) completes inspection of Solara Active Pharma Sciences' API manufacturing facility in Visakhapatna...20 May, 2024, 12.12 PM IST
- Aurobindo's Andhra plant receives 1 observation from USFDA after inspectionAurobindo Pharma has received a Form 483 with one observation from the US FDA after an inspection of its formulation production facility in...20 Sep, 2023, 05.16 PM IST
- 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...14 Jan, 2022, 02.56 PM IST
- 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...10 Oct, 2019, 05.22 PM IST
- Sun Pharma receives 483 for Baska facility, co says responded to USFDAAt the conclusion of the inspection, the US FDA issued a Form 483, with one observation for which the Company has submitted the response to...25 Mar, 2019, 06.27 PM IST
- Good news for Sun Pharma, bad news for Aurobindo: Amit Rajan, Prosfora Tech“India still has to do a lot of things, the FDA’s expectations are increasing day by day.”06 Mar, 2018, 09.51 AM IST
- 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," ...29 May, 2017, 11.23 AM IST
- USFDA notice to Hetero over conditions at Telangana unitThe 13-page observation by investigators Massoud Motamed and Latorie Jones noted several deviations that were against good manufacturing pr...24 Jan, 2017, 01.59 AM IST
- 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...07 Dec, 2016, 03.03 PM IST
- Lapses push Pfizer to shut Chennai unit temporarilyThe site is grappling with adverse reviews for a few years. It was served a warning letter by the US Food and Drug Administration (FDA) in ...08 Aug, 2016, 10.55 AM IST
- Lupin shares fall may be overdone as review minorBut a closer reading of the FDA observations show that they could be of a minor nature and may not lead to any significant impact on earnin...16 Mar, 2016, 02.10 AM IST
- 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 ...25 Mar, 2015, 02.52 PM IST
- USFDA to increase its India headcount"USFDA is in the process of taking the headcount up to 19. We have offices in New Delhi and Mumbai. Currently we have 9 or 10 (officials wo...04 Feb, 2015, 04.42 PM 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
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