Search Results for FDA warning

Showing 1 – 25  of 25

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 Adds Boxed Warning to Janssen's Type 2 Diabetes Drug Label By Zachary Brennan - Published 16 May 2017

Based on new data from two large clinical trials, the US Food and Drug Administration (FDA) on Tuesday concluded that Janssen’s type 2 diabetes medicine canagliflozin (brand names include Invokana, Invokamet and Invokamet XR) causes an increased risk of leg and foot amputations.

Categories: News, Europe, US, EMA, FDA, MHRA, Clinical, Crisis management, Drugs, Postmarket surveillance

Tags: Janssen, SGLT2 inhibitors, FDA warning

FDA Warns Lonza’s Class II Device Manufacturing Site By Zachary Brennan - Published 09 May 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 21 April to Lonza’s contract manufacturing site for Class II devices in Walkersville, MD.

Categories: News, US, CDRH, Biologics and biotechnology, Compliance, Crisis management, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Lonza, medical device manufacturing, FDA warning letter

Numerous Complaints, Repeat Observations Fill FDA Warning Letter for Indoco By Zachary Brennan - Published 12 April 2017

Goa, India-based contract manufacturer Indoco Remedies received a US Food and Drug Administration (FDA) warning letter late last month after the agency said its failure to comply with current good manufacture practices (CGMP) may significantly affect the quality, safety and efficacy of the drugs it manufactures.

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

Tags: FDA warning letter, Indoco Remedies, cGMP

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

FDA Warns Boston Company for Selling Unapproved Biologic to Prevent Peanut Allergies By Zachary Brennan - Published 21 November 2016

The US Food and Drug Administration’s (FDA) Office of Compliance in Biologics Quality in the Center for Biologics Evaluation and Research (CBER) on Monday released an untitled letter sent to Cambridge, MA-based Antera Therapeutics because it's selling an unapproved biologic intended to prevent a peanut allergy.

Categories: News, US, CBER, Biologics and biotechnology, Crisis management, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: peanut allergy, allergenic, FDA warning, untitled letter, Antera, Aralyte

FDA Warns Valeant Over Quality System Violations By Zachary Brennan - Published 08 November 2016

In a letter dated 3 November and released Tuesday, the US Food and Drug Administration (FDA) warned Valeant Pharmaceuticals over quality system violations.

Categories: News, US, FDA, Drugs, Medical Devices, Quality

Tags: Valeant Pharmaceuticals, FDA warning letter

FDA’s OPDP Issues 5th Warning of 2016, Calls out Video’s Misleading Comments By Zachary Brennan - Published 04 November 2016

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) earlier this week sent a letter to Rockville, MD-based Supernus Pharmaceuticals noting that one of its promotional videos makes false or misleading claims and/or representations about the risks associated with Oxtellar XR (oxcarbazepine).

Categories: News, US, FDA, Advertising and Promotion, Drugs, Regulatory intelligence, Regulatory strategy

Tags: OPDP, untitled letter, FDA warning for advertising

FDA Warns Chinese Drug Manufacturer for Limiting Inspection, Systemic Data Manipulation By Zachary Brennan - Published 01 November 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Beijing Taiyang Pharmaceutical Industry Co. on 19 October after the company limited FDA’s ability to conduct an inspection and manipulated manufacturing data.

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

Tags: FDA warning letter, China data manipulation, API manufacturer warning

FDA Warns Four Foreign Drug Manufacturers By Zachary Brennan - Published 11 October 2016

The US Food and Drug Administration (FDA) on Tuesday released four warning letters sent in September to drug manufacturers from China, the UK, the Netherlands and Switzerland.

Categories: News, Asia, Europe, US, FDA, Compliance, Crisis management, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: FDA warning letter, GMP violations, drug manufacturing problems

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

FDA Warns CMO’s Italy Site, Banned Indian API Manufacturer Over GMP Deficiencies By Zachary Brennan - Published 31 May 2016

Contract manufacturing organization (CMO) Corden Pharma’s Sermoneta, Italy-based site and Megafine’s active pharmaceutical ingredient (API) manufacturing site in Nashik, India, both received warning letters from the US Food and Drug Administration (FDA), which were released Tuesday.

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

Tags: FDA warning letter, Corden Pharma, Megafine, pharmaceutical data integrity

FDA Warns German Contract Manufacturer Over API Stability Concerns By Zachary Brennan - Published 24 May 2016

The US Food and Drug Administration (FDA) has warned Baesweiler, Germany-based contract manufacturer BBT Biotech GMBH over deviations from good manufacturing practices (GMPs), including the failure to provide stability data to support expiration dates for active pharmaceutical ingredients (APIs).

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Manufacturing, Postmarket surveillance

Tags: German biotech, BBT Biotech, FDA warning letter, API stability

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 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 Wearable Exoskeleton Manufacturer Over Post-Market Surveillance Failures By Zachary Brennan - Published 01 March 2016

Israel-based Argo Medical Technologies has been warned by the US Food and Drug Administration (FDA) after its failure to conduct post-market surveillance studies for its ReWalk device, which is meant to help individuals with spinal cord injuries to stand upright, walk, turn, and climb and descend stairs.

Categories: News, Middle East, US, CDRH, Crisis management, Due Diligence, Manufacturing, Medical Devices, Postmarket surveillance, Quality

Tags: Argo Medical, ReWalk Robotics, FDA warning letter, 522 Order

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 Warning Letter Calls Out Device Distributor By Zachary Brennan - Published 02 October 2015

When is a device officially a medical device? And when is a distributor officially a manufacturer? The US Food and Drug Administration's (FDA's) latest warning letter to Rhode Island-based Medsource may raise some new questions from companies that don't realize they have to abide by FDA regulations.

Categories: Compliance, Distribution, Due Diligence, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: medical device, medical device distributor, FDA warning letter, FDA