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CGMP VIOLATIONS
USFDA issues warning letter to Intas Pharma for Sanand plantIntas Pharmaceuticals has been criticised by the USFDA for multiple manufacturing faults, including deficiencies in its quality control sys...06 Aug, 2023, 11.25 AM IST- USFDA issues warning to Shilpa Medicare for CGMP violations at Telangana plant"This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceutica...01 Nov, 2020, 11.57 AM IST
- USFDA red flags Torrent Pharma for violation of norms at Indrad facilityStating that company's investigations into testing results were inadequate, the letter said this is a repeat observation from USFDA's April...17 Oct, 2019, 08.32 PM IST
- USFDA issues warning letter to Lantech Pharma for manufacturing violations at Andhra plantIn a warning letter issued to the company's Managing Director V Prakash Reddy, the USFDA said inspectors during March 6-15 this year found ...29 Aug, 2019, 05.07 PM IST
- Strides plunges 8% as USFDA finds significant violation at facilityThe US drug regulator said it also found a blue binder containing CGMP records.17 Jul, 2019, 04.02 PM IST
- FDA pulls up Aurobindo Pharma for 'repeated' failures in CGMPThe FDA recently issued a letter warning the drug- makers unit X1 in Srikakulam district of Andhra Pradesh for deviations from CGMP for API.03 Jul, 2019, 06.33 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
- USFDA issues warning letter to Lupin's Goa, Indore plantsOn Lupin's Pithampur (Indore) plant, the US health regulator said the company invalidated initial OOS laboratory results without adequate i...16 Nov, 2017, 11.43 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
- USFDA issues warning letter to Megafine Pharma for Vapi plantSummarising significant deviations from CGMP norms at the Vapi unit, the US Food and Drug Administration said that its investigators observ...08 Mar, 2017, 08.57 PM IST
- USFDA issues warning letter to ex-Sun Pharma US facilityThe Philadelphia plant is among the two facilities that Sun Pharma had sold to Frontida BioPharm in June this year, along with 15 products,...26 Aug, 2016, 06.31 PM IST
- USFDA warns Sri Krishna Pharma for CGMP norm violationsThe US health regulator said its investigator "identified significant violations of current good manufacturing practice regulations for fin...20 Apr, 2016, 01.10 PM IST
- 'Torn records, ignoring consumer issues at Cadila's 2 plants'Torn notebook with record of 'deficiencies', plastic bags filled with shreds of paperwork, failure to adequately investigate and address co...06 Jan, 2016, 06.59 PM IST
- Leaking ceilings, procedural lapses at Sun Pharma's Halol plant: USFDAThe warning letter follows inspection of the Halol facility in September 2014 by US Food and Drug Administration (USFDA) inspectors.23 Dec, 2015, 09.56 PM IST
- Mylan gets warning letter from USFDA for lapses at 3 unitsUSFDA has issued a warning letter to Mylan Laboratories for violation of current good manufacturing practice norms at its three plants in K...19 Aug, 2015, 09.09 PM IST
- Teva Pharmaceutical recalls 38,858 bottles of drugs made by Emcure Pharmaceuticals in US marketThe company is also recalling 7,694 bottles of anti- inflammatory drug indomethacin 25 mg, produced by Emcure Pharma, for non-adherence to ...22 May, 2014, 05.41 PM IST
- US drug regulator issues warning letter to RPG Life SciencesUSFDA has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants ...19 Jun, 2013, 08.40 PM IST
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