Search Results for warning letter

Showing 1 – 25  of 195

FDA Warns Phototherapy Device Maker for Quality System Issues By Michael Mezher - Published 19 July 2017

The US Food and Drug Administration (FDA) has warned device maker National Biological Corporation for quality systems issues following a two-week inspection of the firm's Beachwood, OH facility last March.

Categories: News, US, FDA, Medical Devices

Tags: Warning Letter, National Biological Corporation

FDA Warns Indian Manufacturer for Equipment in 'State of Disrepair' By Zachary Brennan - Published 11 July 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last week to an India-based pharmaceutical manufacturer for equipment "in a state of disrepair" and failures in validating a manufacturing process for a drug that was distributed in the US from 2014 to 2016.

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

Tags: warning letter, Vista Pharmaceuticals, isoxsuprine hydrochloride

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

FDA Warns Indian Firm for Impeding Inspection By Michael Mezher - Published 09 May 2017

The US Food and Drug Administration (FDA) in April warned Indian pharmaceutical manufacturing company Vikshara Trading & Investments Ltd for attempting to avoid an inspection by pretending its employees were on strike and for poor conditions inside its facility.

Categories: News, India, US, FDA, Compliance, Drugs, Manufacturing

Tags: Inspection, Warning Letter

New FDA Warning Letter, Form 483 for Two Indian Companies By Michael Mezher - Published 02 May 2017

The US Food and Drug Administration (FDA) in April warned Indian active pharmaceutical ingredient (API) maker Sal Pharma and handed an inspection report with six observations to major generic drugmaker Aurobindo Pharma.

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

Tags: Warning Letter, Form 483

FDA Warns Teva API Plant in China By Zachary Brennan - Published 25 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 10 April to Teva for deficiencies related to an active pharmaceutical ingredient (API) manufacturing site in Hangzhou, China.

Categories: News, US, FDA, Active pharmaceutical ingredients, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: Teva, warning letter, FDA inspections

FDA Warns LA-Based Medical Food Company for Clinical Trial Without an IND By Zachary Brennan - Published 18 April 2017

The US Food and Drug Administration (FDA) warning letter released Tuesday says that Los Angeles-based Targeted Medical Pharma ran a clinical investigation of a medical food without first submitting an investigational new drug (IND) application to the agency.

Categories: News, US, FDA, Clinical, Compliance, Crisis management, Nutritional and dietary supplements, Research and development

Tags: warning letter, LA medical foods, medical food clinical trial

FDA Warns Abbott Device Manufacturing Plant in California By Zachary Brennan - Published 13 April 2017

The warning letter sent Wednesday from the US Food and Drug Administration (FDA) details four observations on failures related to corrective and preventive actions (CAPAs), controls, design verification and design validation.

Categories: News, US, FDA, Due Diligence, Medical Devices, Quality

Tags: warning letter, Abbott, St. Jude Medical, ICDs, CRT-Ds

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 Pfizer Clinical Investigator Over Chantix Study By Zachary Brennan - Published 05 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent in January to a clinical investigator working on a study of Pfizer’s nicotine addiction treatment Chantix (varenicline tartrate).

Categories: News, US, FDA, Clinical, Compliance, Drugs, Due Diligence

Tags: Chantix, Pfizer, clinical trial, warning letter

FDA Warns Wockhardt Subsidiary, Says Seven of Company's Facilities Out of Compliance By Michael Mezher - Published 08 March 2017

The US Food and Drug Administration (FDA) has warned Wockhardt subsidiary Morton Grove Pharmaceuticals over quality control and data integrity issues.

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

Tags: Warning Letter, Data Integrity

FDA Warns Pfizer’s Kansas Site Following Cardboard Found in Sterile Injectables By Zachary Brennan - Published 28 February 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to Pfizer subsidiary Hospira’s Kansas-based site, finding that the company’s investigations into complaints of visible particulates in sterile injectables were inadequate.

Categories: News, US, FDA, Crisis management, Drugs, Manufacturing

Tags: Pfizer, Hospira, Copaxone, Teva, warning letter

FDA Warns One Japanese, One Chinese Drugmaker By Michael Mezher - Published 18 January 2017

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to Japanese drugmaker Sato Yakuhin Kogyo Co. Ltd. and Chinese drugmaker Suzhou Pharmaceutical Technology Co., Ltd. earlier this month.

Categories: News, China, Japan, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing, Quality

Tags: Warning Letter, Data Integrity, Import Alert

FDA Warns Wockhardt for Destroying CGMP Documents, Other Violations By Zachary Brennan - Published 03 January 2017

The beleaguered Indian drug manufacturer Wockhardt is in trouble again with the US Food and Drug Administration (FDA), this time for destroying current good manufacturing practice (CGMP) documents, among a list of other major violations.

Categories: News, Asia, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Drugs, Due Diligence, Manufacturing

Tags: warning letter, Wockhardt, CGMP

FDA Warns Chinese Drugmaker for Refusing Inspection, Unsanitary Conditions By Zachary Brennan - Published 20 December 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 8 December to China-based Baoying County Fukang Medical Appliance with six violations.

Categories: News, US, FDA, Crisis management, Drugs, Manufacturing

Tags: warning letter, China drugmaker, mold in manufacturing facility

FDA Warns Spanish API Maker for GMP Violations By Michael Mezher - Published 06 December 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Spanish active pharmaceutical ingredient (API) maker Interquim, S.A. for several good manufacturing practices (GMP) violations uncovered during an inspection of the company's Barcelona facility last May.

Categories: News, Europe, US, FDA, Active pharmaceutical ingredients, APIs, Manufacturing

Tags: Warning Letter, Good Manufacturing Practice, GMP

FDA Warns Chinese Heparin Manufacturer, Reigniting Questions of Contamination By Zachary Brennan - Published 29 November 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to a China-based manufacturer of heparin—the same manufacturer warned by French regulators last March.

Categories: News, Asia, US, FDA, Active pharmaceutical ingredients, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: heparin, warning letter, heparin manufacturers in China

FDA Warns Wockhardt Subsidiary Over Aseptic Production Issues By Michael Mezher - Published 22 November 2016

The US Food and Drug Administration (FDA) sent a warning letter to Wockhardt Limited founder Habil Khorakiwala last week over good manufacturing practice (GMP) violations at the company's CP Pharmaceuticals subsidiary in Wrexham, UK.

Categories: News, Europe, US, FDA, Compliance, Drugs, Manufacturing

Tags: Aseptic Processing, Warning Letter

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 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

FDA Warns Brazilian OTC Drug Manufacturer By Zachary Brennan - Published 04 October 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Brazil’s Mappel Industria de Embalagens last month for four violations, though the over-the-counter (OTC) drug manufacturer told FDA that it did not realize the products were regulated by FDA.

Categories: News, Latin America and Caribbean, US, FDA, Compliance, Crisis management, Over the counter drugs, Ethics, Manufacturing

Tags: warning letter, Brazil OTC drugs, OTC drug regulations

'The Rooms Had Never Been Cleaned': Two New FDA Warning Letters for Chinese Manufacturers By Michael Mezher - Published 27 September 2016

The US Food and Drug Administration (FDA) has sent warning letters to two Chinese active pharmaceutical ingredient (API) makers over data integrity and good manufacturing practice (GMP) violations.

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

Tags: Data integrity, warning letter

FDA Warns Pan Over Data Integrity, Sanitation Issues By Michael Mezher - Published 07 September 2016

For the second time in less than a year, the US Food and Drug Administration (FDA) has issued a warning letter to Indian active pharmaceutical ingredient (API) maker Pan Drugs over data integrity and sanitation violations at one of its facilities.

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

Tags: Data Integrity, Pan Drugs, Warning Letter

FDA Warns 14 International Medical Device Companies By Michael Mezher - Published 16 August 2016

The US Food and Drug Administration (FDA) has released a slew of warning letters—14 in total—sent from the Center for Devices and Radiological Health's (CDRH) Office of Compliance to five device manufacturers located in the UK, three in China, two in Germany, and one each in Argentina, France, Italy and the Philippines.

Categories: News, China, Europe, Latin America and Caribbean, US, CDRH, Medical Devices

Tags: Quality System Regulation, Medical Device Reporting, Corrective and Preventative Action, CAPA, Warning Letter