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OBJECTIONABLE CONDITIONS FDA
No raids till further orders: Maharashtra tells Bombay HC in Patanjali labelling caseThe Maharashtra government has assured the Bombay High Court it will halt raids and confiscations concerning ayurvedic product labels. This...- Biocon's Bengaluru drug manufacturing facility gets 'Voluntary Action Indicated' classificationBiocon Biologics' drug substance facility in Bengaluru has been classified as Voluntary Action Indicated (VAI) by the USFDA. This classific...
- US FDA cited animal lab at Musk's Neuralink for 'objectionable conditions'FDA inspectors identified the issues at Neuralink's animal testing facilities in California in June 2023, several weeks after the agency ha...
- Jubilant gets VAI classification from USFDA for Roorkee unitAs per the USFDA, a VAI inspection classification indicates that although investigators found and documented objectionable conditions durin...
- USFDA issues Form-483 with two observations for Lupin's Nagpur plantLupin's Nagpur facility has received two observations from the USFDA through Form-483 due to violations of the Food Drug and Cosmetic (FD&C...
- Aurobindo Pharma gets VAI classification from USFDA for Hyderabad unitAs per the USFDA, a VAI inspection classification indicates that although investigators found and documented objectionable conditions durin...
- USFDA classifies inspection of Lupin's Tarapur facility as 'Official Action Indicated'According to FDA's definitions, Official Action Indicated means "objectionable conditions were found and regulatory administrative sanction...
- Dr Reddy's gets 4 observations from USFDA for Srikakulam plant"The audit of our API Srikakulam Plant (SEZ), Andhra Pradesh, by the USFDA, has been completed on October 25, 2019. We have been issued a F...
- US FDA seeks voluntary action on Dadra plant in relief for SunSun Pharma's shares had fallen last week over this development as investors worried about delay in product launches from the company.
- USFDA inspects Dahej facility, no observations issued: Ajanta PharmaOur formulation facility at Dahej was inspected by US FDA from July 23-27, 2018. At the end of the inspection, no Form 483 was issued to us...
- Dr Reddy's tumbles on USFDA inspection report, recoversThe stock cut down initial losses and was trading 2.22 per cent down at Rs 2,121.
- Dr Reddy's gets EIR from USFDA for Srikakulam plantDr Reddy's today said it has received the establishment inspection report (EIR) from the USFDA for its its formulations facility in Srikaku...
- Aurobindo Pharma gains 2% as USFDA grants VAI to Hyderabad Unit IV; ends flatThe classification suggested that the matter has not escalated to the extent of slapping warnings letter or import alert.
- 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," ...
- Strides Shasun's plant completes successful USFDA inspectionThe company remains committed to meeting the expectation of the authorities in the challenging regulatory landscape as it continues to evol...
- 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...
- USFDA inspects Cadila Healthcare's Moraiya facility"USFDA inspected company's Moraiya facility from February 6, 2017 to February 15, 2017. At the end of the inspection no observation (483) i...
- 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...
- 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...
- USFDA completes Wockhardt's Nalagarh facility inspectionWockhardt, which has been under the USFDA scanner, today said that United States health regulator has completed inspection of its facility.
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