Laurus Labs has received an untitled letter from the USFDA, dated May 16, 2024, concerning its drug manufacturing facility, Laurus Synthesis, located in Andhra Pradesh. The letter, which resembles a warning letter, follows a review of Laurus Labs' response in January 2024, highlighting observed deviations. In a separate development, Gland Pharma's API unit in Vizag was inspected by the USFDA from May 20-24, 2024, resulting in a Form 483 with zero observations. Additionally, Aurobindo Pharma's Eugia formulation manufacturing unit in Pashamylaram, Telangana, has been classified by the USFDA as 'Official Action Indicated' following an inspection conducted from January 22 to February 2, 2024.
JUST IN | Aurobindo Pharma: USFDA classifies Eugia Pharma's Telangana Facility as 'Official Action Indicated' https://t.co/Trlb764QZP
#JustIN | US FDA classifies #AurobindoPharma arm Eugia’s formulation mfg unit at Pashamylaram, Telangana as official action indicated Alert: US FDA Conducted An Inspection At Eugia’s Pashamylaram Unit From Jan 22 -Feb 2, 2024 https://t.co/tSKqmjvyOx
Check out the latest FDA Roundup, our at-a-glance summary of agency updates: https://t.co/EmIzCcb5rW Yesterday, we announced Medline Industries, LP, a firm marketing and distributing plastic syringes made in China within the U.S., initiated a recall to stop using affected… https://t.co/drXZ96vqm2
#JustIn | #USFDA issues Form 483 with zero observations for #GlandPharma’s API unit in #Vizag Alert: US FDA conducted inspection at API unit in Vizag from May 20-24, 2024 https://t.co/NURj23WbsG
Stocks In News | Laurus Labs receives letter from USFDA; letter format looks like that of warning letter https://t.co/ONqmHx3DDZ
#USFDA issued untitled letter to #LaurusLabs, dated May 16, 2024, letter deals with Drug Manufacturing Facility Laurus Synthesis located in AP US FDA says they reviewed Laurus’s response in January 2024 & observed following deviations 👇 https://t.co/NrlU03b3lT
Stokes In News | Laurus Labs receives letter from USFDA; letter format looks like that of warning letter https://t.co/g0maJxfXyn
[new post] We Received a 483 After an FDA Inspection – Now What? https://t.co/Hras67rk3H #qualityassurance #pharma https://t.co/ztHwox659h