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FDA STERILITY WARNING
American scientists and ranchers are racing to stop a flesh-eating fly after 15 animal cases turned up in Texas and New Mexico, and the battle could take more than a year- Urgent recall: 3 million eye drop bottles recalled after FDA sterility warning - are you using it?
- USFDA pulls up Eugia for manufacturing lapses, data accuracy at Hyderabad plant
- USFDA issues warning letter to Kilitch Healthcare for Navi-Mumbai plantThe US Food and Drug Administration (USFDA) has issued a warning letter to Kilitch Healthcare India for manufacturing lapses at its plant i...11 Apr, 2024, 03.52 PM IST
- USFDA pulls up Cipla for manufacturing lapses at Pithampur plantA warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. "Your firm fa...22 Nov, 2023, 08.30 PM IST
- Indian eyedrop maker issues recall of various eye drops in US for potential safety reasonsKilitch Healthcare India Limited has recalled 27 types of eye drops sold in the U.S. due to safety concerns arising from insanitary conditi...16 Nov, 2023, 11.31 AM IST
- FDA warns consumers of infection risk in over-the-counter eyedropsThe FDA warns against using over two dozen over-the-counter eyedrops due to infection risk, potentially leading to blindness. This advisory...31 Oct, 2023, 07.03 PM IST
- Pharma cos staring at some margin pressure: Surajit Pal, Prabhudas Lilladher"Non-sterile plants getting stuck for such a long time are really surprising."18 Mar, 2019, 06.17 PM IST
- Pharma cos have not worked on compliance issues: Amit Rajan, Prosfora TechConcern remains over Indian pharma’s sterile manufacturing practices, says Prosfora Tech MD18 Mar, 2019, 02.31 PM IST
- Injectable units under cloud as India lacks experts in aseptic practices: Amit Rajan, Prosfora TechIndian pharma cos putting up ANDAs and APIs in one plant to avoid paying GDUFA fee, says Rajan.19 Feb, 2019, 03.52 PM IST
- USFDA issues warning letter to Fresenius Kabi for Baddi plantThe regulator also asked Fresenius Kabi AG to ensure sufficient investigation of potential vulnerabilities in the manufacturing operation a...03 Jan, 2018, 08.50 PM IST
- Reusing single-use devices: FDA warns Fortis hospitalsFortis had received the notices and was "evaluating the observations" and would respond appropriately, its spokesperson told PTI.27 Apr, 2017, 11.55 PM IST
- USFDA issues warning letter to USV Pvt over Daman plantThe warning letter to Managing Director Prashant K Tewari raised similar current good manufacturing practice (CGMP) violations at its other...23 Mar, 2017, 04.52 PM IST
- The jewel of the Indian pharma crown has lost its shine: Amit Ranjan on Sun PharmaSun Pharma got two inspections – one for Mohali and one for Halol sight – and if you summarise, I am sorry to say that the jewel of the Ind...14 Dec, 2016, 03.58 PM IST
- USFDA issues warning letter to Wockhardt's UK facilityThe significant violations included non-adherence to appropriate written procedures that are designed to prevent contamination of drugs.24 Nov, 2016, 01.30 AM IST
- Sun Pharma needs to fix leaking roof, contamination risks at Halol: USFDAThe US FDA has directed Sun Pharma to systematically improve the oversight of manufacturing quality to ensure sustainable quality assurance.24 Dec, 2015, 05.52 AM IST
- Jubilant Life Sciences gets warning letter from USFDAJLL received a warning letter from the USFDA over violation of manufacturing norms at one of its plants located in Washington state.05 Dec, 2013, 02.29 PM IST
- USFDA warning letter to Agila not to affect acquisition: MylanMylan said the USFDA warning letter to Agila Specialties over violation of manufacturing norms in one of its plants will not affect the Rs ...17 Sep, 2013, 06.02 PM IST
- US regulator blocks entry of 30 Ranbaxy medicinesIn a severe setback for Ranbaxy, the US FDA has banned entry in the US of over 30 medicines manufactured by the drug maker at two of its In...18 Sep, 2008, 04.29 AM IST
- US FDA warns Merck to clean up violations at plantThe Food and Drug Administration has ordered Merck & Co to correct numerous manufacturing deficiencies at its main vaccine plant, the lates...01 May, 2008, 02.46 AM IST
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