Cadila Healthcare Moraiya plant gets USFDA warning letter for significant violations of CGMP Medical Dialogues Bureau16 Nov 2019 11:11 AM ISTCadila Healthcare failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilise equipment and utensils at...
New USFDA warning letters show Glenmark, Lupin, Cadila Healthcare in trouble Medical Dialogues Bureau7 Nov 2019 4:20 PM ISTCadila Healthcare Ltd., Glenmark Pharmaceuticals Ltd. and Lupin Ltd. are the latest local medicine makers to be reprimanded by the US Food and Drug...
Aurobindo Pharma Unit-7 documents inaccurate, misleading: USFDA Medical Dialogues Bureau11 Oct 2019 10:00 AM IST"The responsibilities and procedures applicable to the quality control unit are not fully followed. Several lists of documents requested were either...
Torrent Pharma shares slump 3pc on USFDA warning letter for Gujarat facility Medical Dialogues Bureau11 Oct 2019 9:15 AM ISTTorrent Pharma does not believe that the warning letter will have an impact on the disruption of supplies or the existing revenues from operations of...
Emcure Pharma gets USFDA Warning Letter for Manufacturing Violations at Pune plant Medical Dialogues Bureau16 Aug 2019 9:45 AM ISTIn the letter, the USFDA said inspectors during February 11-20 this year found significant deviations from standard manufacturing practices at Emcure...
Indoco Remedies receives EIR from USFDA for sterile, solid dosages facility in Goa Medical Dialogues Bureau27 July 2019 9:45 AM ISTThe inspection was held from May 27-June 4, 2019 and the company received four Form 483 observations, Indoco Remedies said in a filing to BSE.NEW...
Indoco Remedies gets USFDA warning letter for significant violations at Goa facility Medical Dialogues Bureau26 July 2019 9:30 AM ISTStating the specific violations, the US Food and Drug Administration (USFDA) said Indoco Remedies failed to prepare batch production and control...
USFDA Warning: Medtronic recalls insulin pumps over cybersecurity vulnerabilities Medical Dialogues Bureau29 Jun 2019 1:49 PM ISTThe recalled pumps are Medtronic's MiniMed 508 insulin pump and MiniMed Paradigm series insulin pumps. Medtronic is unable to adequately update the...
Certain Medtronic pacemaker batteries fail without warning; USFDA flags issue Farhat Nasim13 May 2019 9:33 AM ISTNew Delhi: US Food and Drug Administration (FDA) has recently issued safety alarm about premature battery depletion without warning patients or health...
