Searched for
CGMP VIOLATIONS
Warning letter: USFDA pulls up Sun Pharma for manufacturing issues at Dadra facility"Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitise and/or sterilise equipment and utensils at a...- 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...
- 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...
- 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...
- 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...
- 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...
- 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 ...
- Strides plunges 8% as USFDA finds significant violation at facilityThe US drug regulator said it also found a blue binder containing CGMP records.
- 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.
- 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...
- 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...
- 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...
- 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...
- 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,...
- 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...
- '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...
- 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.
- 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...
- 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 ...
- 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 ...
Load More
