Search Results for warning letters

Showing 1 – 25  of 36

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 14 Companies for Selling Fake Cancer Treatments By Michael Mezher - Published 25 April 2017

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to 14 US-based companies for selling dozens of unapproved cancer treatments online and through social media.

Categories: News, US, FDA

Tags: Warning Letters, Misbranded Drugs, Fake Cancer Treatments

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

New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India By Zachary Brennan - Published 14 March 2017

The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis Global Pharmaceuticals, both sent 2 March.

Categories: News, Asia, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Government affairs

Tags: warning letters, API manufacturers, water and pharmaceuticals

CDRH and CDER Send Warning Letters to Six Asian Companies By Zachary Brennan - Published 14 February 2017

The flurry of US Food and Drug Administration (FDA) warning letters continued on Tuesday with the release of six new warning letters for pharmaceutical and medical device companies in China, India, Taiwan and Japan.

Categories: News, Asia, US, FDA, Active pharmaceutical ingredients, Drugs, Government affairs, Manufacturing, Medical Devices, Quality

Tags: warning letters, China drug manufacturing, India drug manufacturing

CDRH Warns Three Foreign Medical Device Manufacturers By Zachary Brennan - Published 07 February 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device manufacturers in Taiwan, China and South Korea.

Categories: News, US, CDRH, Compliance, Manufacturing, Medical Devices

Tags: warning letters, quality data

FDA Warns Five Medical Device, Three Pharma Companies By Zachary Brennan - Published 31 January 2017

The US Food and Drug Administration (FDA) on Tuesday released warning letters for five medical device companies and three pharmaceutical firms located in India, China, Canada, Korea, Germany and Italy – further revealing the depth of the agency’s international work.

Categories: News, Asia, Canada, Europe, US, FDA, Drugs, Medical Devices, Quality

Tags: warning letters

FDA Warns Two Pharma Companies Over Misleading Ads By Zachary Brennan - Published 16 December 2016

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent two warning letters earlier this week for misleading advertisements.

Categories: News, US, FDA, Advertising and Promotion, Drugs

Tags: pharmaceutical advertising, warning letters

FDA Warns Teva’s Banned Hungary Manufacturing Facility By Zachary Brennan - Published 19 October 2016

The US Food and Drug Administration (FDA) has warned Teva’s Gödöllő, Hungary-based manufacturing site, citing deficiencies in manufacturing operations and laboratory controls, as well as the company’s data integrity program.

Categories: News, Europe, FDA, Compliance, Crisis management, Drugs, Government affairs, Manufacturing

Tags: warning letters, Teva, data integrity

FDA Warns Japanese Company for Impeding Inspection By Michael Mezher - Published 06 October 2016

The US Food and Drug Administration (FDA) has warned Japanese active pharmaceutical ingredient (API) maker Nippon Fine Chemical Co., Ltd for impeding an FDA investigator from conducting an inspection of the company's facility in Takasago City, Japan, last December.

Categories: News, Asia, US, FDA, MHLW, PMDA, Active pharmaceutical ingredients, Compliance, Crisis management, Drugs

Tags: warning letters, Nippon Fine Chemical, FDA inspections

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: Foreign Device Inspections on the Rise By Michael Mezher - Published 17 March 2016

Newly released data shows the US Food and Drug Administration (FDA) conducted fewer medical device quality systems inspections in 2015 compared to recent years, while the number of foreign inspections increased to their highest number in a single year.

Categories: News, CDRH, Compliance, Medical Devices

Tags: Quality Systems, Inspections, Warning Letters, OAI, VAI, NAI

FDA Warns Indian Pharma Company Over Repeat Data Manipulation Violations By Zachary Brennan - Published 15 March 2016

The US Food and Drug Administration (FDA) has warned India-based Emcure Pharmaceuticals for repeated data manipulation and falsification.

Categories: News, India, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing

Tags: Emcure Pharmaceuticals, Indian drug company warning letters from FDA, warning letter

FDA Warns Indian Drugmaker Over Major Data Integrity Violations at Three Plants By Zachary Brennan - Published 09 February 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter to India-based Ipca Laboratories after inspections at three of its manufacturing facilities revealed data integrity violations. All three of the plants are already banned from sending products to the US.

Categories: News, India, US, FDA, Active pharmaceutical ingredients, Audit, Crisis management, Drugs, Manufacturing

Tags: Ipca Laboratories, data integrity violations, GMP warning letters

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

FDA Form 483s From India: A Deep Dive Into the Problems By Zachary Brennan - Published 09 November 2015

A Focus review (thanks to the Freedom of Information Act) of 50 Form 483s issued by the US Food and Drug Administration (FDA) to Indian pharmaceutical and active pharmaceutical ingredient (API) manufacturers over the past two years reveals a slew of detailed quality concerns from the agency.

Categories: News, India, US, CDSCO, FDA, Active pharmaceutical ingredients, Audit, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Quality

Tags: India, Form 483s, Wockhardt, Glenmark, Hospira, CDSCO, warning letters

Correlation Between OPDP Untitled or Warning Letters and OIG Settlements or Corporate Integrity Agreements with Sponsors By Betsy Kurian, PharmD, Moulakshi Roychowdhury, PharmD, JD - Published 09 October 2015

This article discusses the existence of a correlation between OPDP enforcement letters and OIG settlements or corporate integrity agreements with pharmaceutical companies.

Categories: Features, US, FDA, Advertising and Promotion, Compliance, Prescription drugs, Government affairs

Tags: Office of Prescription Drug Promotion, OPDP, Office of Inspector General, (OIG), Untitled letters, Warning letters

In Transparency Move, FDA Makes its Enforcement Data Easier to View By Alexander Gaffney, RAC - Published 02 October 2014

The US Food and Drug Administration (FDA) has just unveiled a new web-based tool intended to make it easier to dive into the agency's regulatory enforcement data.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Data Dashboard, Enforcement Data, FDA Data Dashboard, Warning Letters, Site Inspections

Colgate, Other Generic Companies Hit by FDA for Failure to Pay Facility Fees By Alexander Gaffney, RAC - Published 26 August 2014

The US Food and Drug Administration (FDA) this week issued an unprecedented four Warning Letters to companies, including the consumer healthcare company Colgate, for failing to pay user fees as part of the Generic Drug User Fee Act (GDUFA).

Categories: News, US, CDER, Active pharmaceutical ingredients, Generic drugs, Manufacturing, Submission and registration

Tags: Warning Letter, Warning Letters, GDUFA, GDUFA Facility Fee, FDA Facility Fee, Facility Registration Fee