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CGMP REGULATIONS
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 Intas Pharma for manufacturing lapses at Ahmedabad plantIn a warning letter to the company's CEO and MD Nimish Chudgar, the US Food and Drug Administration (USFDA) has pointed out various manufac...10 Dec, 2023, 11.00 AM 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
- 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 pulls up Sun Pharma for lapses in Halol plant"This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceutica...14 Jan, 2023, 11.33 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
- 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 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 warns Bengaluru-based Resonance Labs of manufacturing norms violationsAlthough the company committed to addressing issues identified with the water systems and cleaning validation, the overall response lacked ...15 Feb, 2017, 08.31 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
- 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
- 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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