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CGMP DEVIATIONS
Over 67,000 cases of deodorants sold at Walmart, Amazon recalled due to 'cGMP deviations'. What is it?Over 67,000 cases of Power Stick deodorant sold at major retailers like Walmart, Amazon, and Dollar Tree have been voluntarily recalled. Th...- Glenmark, Sun Pharma, Zydus recall products in USGlenmark, Sun Pharma, and Zydus are recalling various products in the US due to manufacturing issues and CGMP deviations, according to the ...
- USFDA pulls up Granules India for lapses in maintaining storage facilities, equipment at Telangana plantThe USFDA has issued a warning to Granules India for contamination and improper equipment maintenance at its Telangana facility. Inspectors...
- USFDA pulls up Jagsonpal Pharmaceuticals for manufacturing lapses at API plantThe USFDA has issued a warning to Jagsonpal Pharmaceuticals following an inspection of its API plant in Rajasthan. The regulator highlighte...
- 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 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...
- Macleods Pharmaceuticals recalls products in US for manufacturing issuesThe company had produced the affected lot at its Baddi plant and later marketed in the US market by Macleods Pharma USA Inc.
- Drug makers Glenmark, Aurobindo recall products in USGlenmark Pharmaceuticals Inc, USA is recalling Fulvestrant injection, Naproxen Sodium Tablets, Chlorzoxazone tablets and Arformoterol Tartr...
- USFDA pulls up Mylan for manufacturing violations at Andhra plantIn a warning letter issued to the company's CEO Heather Bresch, the US Food and Drug Administration (USFDA) said inspectors during May 27 t...
- Jubilant Cadista Inc recalls 63,216 bottles of erosive esophagitis tabletsThe reason for the recall is "CGMP Deviation: Presence of dark brown discoloration on edges of tablets," USFDA said. The ongoing voluntary ...
- 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 ...
- 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 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 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 ...
- USFDA issues warning letter to Megafine PharmaIt also pulled up the company for conducting "inadequate investigation of critical deviations or a failure of a batch to meet its specifica...
- US FDA warns Dr Reddy's Laboratories of ban if flaws are not fixedUS FDA may also withhold approval of new applications from Dr Reddy’s if it fails to complete all corrections, it said in a letter dated No...
- Wockhardt recalls over 1.62 lakh cartons of drugs in USs per the information available on the US Food and Drug Administration's (USFDA) website, Mumbai-based Wockhardt is recalling the drugs for...
- US FDA cites Apotex's Indian drug facility for fraudulent dataAn Indian subsidiary of Apotex manipulated laboratory data, retesting samples until the results were acceptable, according to a warning let...
- 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 ...
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