Search Results for FDA warning letters

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FDA Warns Swedish IVD Manufacturer By Zachary Brennan - Published 10 October 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 20 September to Malmo, Sweden-based Euro Diagnostica AB, which manufactures multiple class II in vitro diagnostic (IVD) devices.

Categories: News, Europe, US, CDRH, Compliance, Due Diligence, In vitro diagnostics, Medical Devices, Quality

Tags: FDA warning letters, IVD manufacturer warning letter, Euro Diagnostica

FDA Warns Korean, Chinese Drugmakers By Zachary Brennan - Published 19 September 2017

The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent recently to Korea-based Firson Co. and China's Wuxi Medical Instrument Factory detailing the firms' violations.

Categories: News, Asia, US, FDA, Drugs, Manufacturing

Tags: FDA warning letters, Wuxi Medical, Firson

FDA Warns Indian Contract Manufacturer Hetero Labs By Zachary Brennan - Published 29 August 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to India-based contract manufacturer Hetero Labs’ manufacturing site on the outskirts of Hyderabad for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.

Categories: News, India, FDA, Drugs, Due Diligence, Manufacturing

Tags: Hetero Labs, FDA warning letters

Chinese Heparin Contamination Questions Return With New FDA Warning Letter By Zachary Brennan - Published 05 July 2017

The US Food and Drug Administration (FDA) released a warning letter on Wednesday for China-based heparin contract testing lab, Shandong Analysis and Test Center, reigniting a debate over whether the questionable sources of heparin that led to almost 100 American deaths a decade ago have been rooted out.

Categories: News, China, US, FDA, Crisis management, Drugs, Government affairs, Manufacturing

Tags: heparin, Chinese heparin, heparin contamination, FDA warning letters

FDA Warns B. Braun Medical’s California Plant for Repeat Violations By Zachary Brennan - Published 31 May 2017

The US Food and Drug Administration (FDA) earlier this month sent a warning letter to B. Braun Medical’s Irvine, CA-based manufacturing facility for repeat violations also uncovered during inspections in 2013, 2014 and 2015.

Categories: News, US, FDA, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: B. Braun Medical, FDA warning letters, field alert reports, leaking IV bags

FDA Warns Chinese API Manufacturer for a Lack of Written and Quality-Related Procedures By Zachary Brennan - Published 23 May 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to China-based active pharmaceutical ingredient (API) manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory for, among other issues, failing to have written procedures on its handling of raw materials.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Crisis management, Manufacturing

Tags: FDA warning letters, China API manufacturers

FDA Warns Singapore Ophthalmic Drug Manufacturing Site By Zachary Brennan - Published 28 March 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 16 March to Singapore-based Opto-Pharm for its failure to address leaking containers and bottle defects, among other violations.

Categories: News, US, FDA, Drugs, Manufacturing, Regulatory strategy

Tags: sterile eye wash, FDA warning letters

Flying Insects and Chipping Paint: FDA Warns Chinese API Manufacturer By Zachary Brennan - Published 30 August 2016

Two of Xinxiang Pharmaceutical’s China-based manufacturing facilities received a US Food and Drug Administration (FDA) warning letter on 19 August after FDA inspectors found drug manufacturing equipment and facilities in such a state of disrepair as to be unsalvageable.

Categories: News, China, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Government affairs, Manufacturing, Product withdrawl and retirement, Quality

Tags: Chinese API manufacturing, FDA warning letters

FDA Warns Taiwanese Drug Manufacturer Over Significant cGMP Violations By Zachary Brennan - Published 07 June 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter for Taiwanese drug and contract manufacturer Ko Da Pharmaceutical over four specific violations.

Categories: News, China, FDA, Compliance, Drugs, Government affairs, Manufacturing

Tags: Taiwan drug manufacturing, cGMP violations, FDA warning letters

Updated: FDA Warns Banned Indian API Manufacturer Over Filth, Incomplete Complaint Records By Zachary Brennan - Published 28 April 2016

Mumbai-based active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories is quickly turning into the poster child for how to run afoul of nearly every major pharmaceutical regulator.

Categories: News, Canada, Europe, US, FDA, Health Canada, Active pharmaceutical ingredients, Compliance, Crisis management, Drugs, Ethics, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: Indian drug manufacturing, Indian API manufacturing, Polydrug Laboratories, product quality complaints, FDA warning letters

FDA Continues Crackdown on Noncompliant Chinese Pharmaceutical Manufacturers By Zachary Brennan - Published 08 April 2016

Three more Chinese pharmaceutical companies were added to two US Food and Drug Administration (FDA) import alert lists this week for failing to meet the good manufacturing practice (GMP) standards of FDA and for refusing an FDA inspection.

Categories: News, China, US, CDER, Combination products, Compliance, Crisis management, Drugs, Due Diligence, Government affairs, Manufacturing, Quality

Tags: China drug manufacturing, Chinese heparin, FDA inspections in China, FDA warning letters for Chinese pharma

FDA Warns Chinese API Manufacturer for Serious Data Manipulation By Zachary Brennan - Published 12 January 2016

The US Food and Drug Administration (FDA) has warned China-based Zhejiang Hisun Pharmaceutical, which established a joint venture with Pfizer in 2012, for data integrity violations more than three months after banning the company’s products from entering the US.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Drugs, Manufacturing, Postmarket surveillance, Quality, Regulatory intelligence

Tags: FDA warning letters, Hisun, Pfizer, Merck

FDA Warns Sandoz, Dr. Reddy’s Indian Sites Over Data Integrity Violations By Zachary Brennan - Published 24 November 2015

Serious data integrity violations, including the backdating of records and failing to provide pertinent data to regulators, were included in warning letters for five manufacturing facilities from both Sandoz and Dr. Reddy’s in India, according to the US Food and Drug Administration (FDA).

Categories: News, India, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Clinical, Crisis management, Drugs, Government affairs, Manufacturing, Quality

Tags: Sandoz, Dr. Reddy's, FDA, warning letters, warning letters in India