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FDA REGULATIONS VIOLATION
Plan in the works to let hospitals import med equipment directlyIndia's drug regulator is proposing to allow hospitals to directly import advanced medical equipment like MRI and CT scanners, bypassing cu...- US drug regulator issues import alert for drugs made at a Dabur India plantThe US Food and Drug Administration has placed Dabur India's factory on an import alert. This action follows an inspection that revealed si...
- Drugmaker Granules to tighten oversight after US FDA warning, executive saysThe company, which is globally one of the largest paracetamol makers and a major player in the active pharmaceutical ingredients market, de...
- Indian drugmaker Granules to tighten oversight after US FDA warning, exec saysAmid growing scrutiny from the U.S. FDA over documentation practices and contamination issues, Granules India is reinforcing its manufactur...
- US FDA finds quality control, equipment issues at Alembic Pharma unitEarlier this month, the US drug regulator had issued a ‘Form 483’ to the facility of the drug company with five observations.
- 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 Lupin for significant violations at MP unitThe USFDA said it had inspected the Unit 1 at the Mandideep facility of the company from November 26 to December 4, 2018.
- 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 ...
- 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 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...
- 181 food licences in Thane cancelled for FDA rule violationOf the total food samples inspected last year, 105 were found to be sub-standard and 30 unfit for human consumption.
- USFDA issues warning letter to Emcure PharmaceuticalsThe US Food and Drug Administration (USFDA) has issued a warning letter to Emcure Pharmaceuticals for violating current good manufacturing ...
- 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...
- US clamps down on sale of 'natural' diabetes drugs from IndiaUS health regulator FDA has initiated action against 15 companies for supply of illegal sale of India-originating drugs.
- 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 ...
- USFDA revoke's warning to Cadila HealthcareThe US drug regulator has revoked its earlier warning letter to Ahmedabad-based Cadila Healthcare Ltd.
- USFDA warns Sun Pharma on plant problemsThe US health regulator has served a warning letter on the American unit of Mumbai-based drug major Sun Pharma for violating good manufactu...
- Unhappy FDA tells Ranbaxy to review unitsThe US drugs regulator has asked Indian pharma company Ranbaxy to immediately assess the manufacturing practices at its plants that make dr...
- FDA comes under Congress scanner over Ranbaxy issueFDA, which has charged Ranbaxy with selling unsafe medicines in the country, has come under the Congress scanner and will be probed for its...
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