Search Results for Form 483

Showing 1 – 25  of 25

Preparing for and Managing FDA Inspections By Sharry Arora, Bhaskar Saxena - Published 13 December 2017

The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish.

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

Tags: Inspections, GxP, Quality Management System, QMS, CAPA, CMC, Validation, Form 483, Quality Assurance

FDA Finds Quality Documents Stuck in a Shredder at Glenmark Facility By Zachary Brennan - Published 05 December 2017

The US Food and Drug Administration (FDA) on Tuesday released a heavily redacted Form 483 sent last month to Glenmark Pharmaceuticals' Solan, India-based manufacturing facility.

Categories: News, US, FDA, Crisis management, Drugs, Ethics, Regulatory strategy

Tags: Glenmark Pharmaceuticals, Form 483

Updated: FDA Form 483 for Celltrion Site Manufacturing Remicade Biosimilar By Zachary Brennan - Published 06 September 2017

The US Food and Drug Administration (FDA) on Wednesday released a Form 483 sent to Korea’s Celltrion with 12 observations, which an industry analyst believes could be the reason why the commercialization of Celltrion and Pfizer’s Inflectra (infliximab-dyyb), a biosimilar to Remicade, has not gone as well as planned in the US.

Categories: News, Asia, US, FDA, Biologics and biotechnology, Crisis management

Tags: Celltrion, Form 483, Pfizer, Inflectra

FDA: Lead Test Company May Have Violated Federal Law By Michael Mezher - Published 13 July 2017

The US Food and Drug Administration (FDA) on Thursday said that lead test maker Magellan Diagnostics may have violated federal law in its handling of customer complaints and design validation for its LeadCare testing systems.

Categories: News, US, CDRH, In vitro diagnostics

Tags: LeadCare, Lead Testing, Magellan Diagnostics, Form 483

FDA Issues 483 to Repro-Med Over Reporting, Quality Systems Issues By Michael Mezher - Published 24 May 2017

The US Food and Drug Administration (FDA) has issued an inspection report detailing eight observations to medical device maker Repro-Med Systems following a seven-day inspection of the company's Chester, NY facility in late 2016.

Categories: News, US, FDA, Medical Devices

Tags: Form 483

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 Issues Form 483 for Lupin's Goa Facility By Michael Mezher - Published 28 April 2017

The US Food and Drug Administration (FDA) has issued an inspection report to major Indian generic drugmaker Lupin Limited following an inspection of its Goa, India facility earlier this month.

Categories: News, India, US, FDA, Generic drugs, Manufacturing

Tags: Form 483, Lupin

A Peek Behind the Curtain: 706 FDA Form 483 Requests in 2016 for Indian and Chinese Manufacturers By Zachary Brennan - Published 06 April 2017

As China and India continue to manufacture about 80% of all active pharmaceutical ingredients (APIs) for the US market, the US Food and Drug Administration (FDA) is tasked with regulating these manufacturing sites and in 2016 that involved issuing hundreds of Form 483s and responding to more than 700 requests for the inspection reports.

Categories: News, Asia, US, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Government affairs, Manufacturing

Tags: Form 483, FDA inspection reports, API manufacturing

FDA Form 483 Cites 14 Observations for Zimmer Biomet By Zachary Brennan - Published 19 January 2017

Just a day before Rep. Tom Price (R-GA) was grilled by senators over his links to the medical device company Zimmer Biomet, the US Food and Drug Administration (FDA) released a Form 483 for the company’s Warsaw, IN-based site with 14 observations.

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

Tags: Zimmer Biomet, Form 483, CAPA

FDA Sends Form 483 to Sterile Manufacturer Akorn Pharmaceuticals’ Illinois Plant By Zachary Brennan - Published 18 October 2016

The US Food and Drug Administration (FDA) on Tuesday released a Form 483 (which can be the precursor to a warning letter) with six observations to one of two Akorn Pharmaceuticals’ Decatur, Illinois-based sterile drug manufacturing facilities.

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

Tags: Form 483, Akorn Pharmaceuticals, human error

FDA Form 483: Theranos Initiated Trials Without IRB Approval By Zachary Brennan - Published 09 September 2016

The US Food and Drug Administration (FDA) on Friday released a Form 483 issued 18 August to blood testing startup Theranos, citing the company for allowing patients to consent to sample collection in two Zika-related trials without approval of an institutional review board (IRB).

Categories: News, US, FDA, Ethics, Government affairs, In vitro diagnostics, Medical Devices

Tags: Theranos, Elizabeth Holmes, Zika, Form 483

FDA Hits Valeant’s Bausch & Lomb With Form 483 By Zachary Brennan - Published 06 September 2016

The US Food and Drug Administration (FDA) on Tuesday released a Form 483 for Valeant’s Bausch & Lomb sterile drug manufacturing facility in Tampa, FL, citing the site for microbiological contamination of drugs purporting to be sterile.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Due Diligence, Government affairs

Tags: Valeant Pharmaceuticals, Bausch & Lomb, FDA Form 483

Form 483 Details Deficiencies at Catalent Facility Linked to Recent CRL By Michael Mezher - Published 19 April 2016

The US Food and Drug Administration (FDA) last week released an inspection report citing major deficiencies at pharmaceutical contract manufacturer Catalent's Saint Petersburg, FL facility.

Tags: Form 483, Catalent

US FDA Inspections in China: An Analysis of Form 483s from 2015 By Zachary Brennan - Published 10 February 2016

As the US becomes increasingly dependent on Chinese and Indian active pharmaceutical ingredient (API) and drug manufacturing, a deeper look into the inspection reports from the US Food and Drug Administration (FDA) in China reveals a number of question marks that parallel the same sort of issues found in Form 483s issued after inspections in India.

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

Tags: Form 483s, FDA in China, CFDA, API inspections

FDA Warns Cancer Center Over Unsanitary Conditions By Michael Mezher - Published 11 November 2015

The US Food and Drug Administration (FDA) has warned the Connecticut-based Johnson Memorial Cancer Center over unsanitary conditions in areas where the center prepares sterile drugs.

Categories: News, US, FDA, Compliance, Prescription drugs, Manufacturing

Tags: Form 483, Warning Letter, Johnson Memorial Cancer Center, ISO 7, ISO 5, HEPA Filters

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

FDA Details Theranos Deficiencies in Two Form 483s By Zachary Brennan - Published 27 October 2015

The heavily-redacted Form 483s released by the US Food and Drug Administration (FDA) on Tuesday for the blood testing company Theranos include 14 observations, with several on device design, classification and on how the company deals with complaints.

Categories: News, US, FDA, Blood, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: Theranos, Elizabeth Holmes, FDA, Form 483

NIH Suspends Drug Production Unit After FDA Inspection Finds Major Problems By Alexander Gaffney, RAC - Published 05 June 2015

Pharmaceutical companies frequently find themselves sanctioned by the US Food and Drug Administration (FDA) for failing to adhere to federal good manufacturing practice (GMP) requirements. But it's an exceptionally rare occurrence to see FDA cracking down on a fellow federal government agency, as it is this week.

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

Tags: PDS, National Institutes of Health, Pharmaceutical Compounding, Form 483

FDA Chides Contact Lens Manufacturer for Ignoring Earlier Warning By Alexander Gaffney, RAC - Published 15 April 2015

A recent Warning Letter sent by the US Food and Drug Administration (FDA) to a medical device manufacturer contains good advice to any firm facing an enforcement action from federal regulators: Ignoring the issue will not make it go away.

Categories: News, CDRH, Compliance, Medical Devices, Quality

Tags: Warning Letter, Form FDA 483, Form 483

The Tip of the Iceberg: What Lurks Beneath the 483 By Marlene S. Bobka, FOI Services, Sharon DeGrove Bishop, RAC - Published 23 March 2015

At the end of a grueling week spent sitting in a conference room with an investigator from the US Food and Drug Administration (FDA), you may end up with an FDA Form 483 listing the inspectional observations that the agency has cited as potentially deficient.

Categories: News, US, FDA, Audit, Regulatory intelligence, Regulatory strategy

Tags: RIQ, Regulatory Intelligence Quotient, Graematter, FDA Form 483, Form 483, EIR, Establishment Information Report

The Top 15 Pharmaceutical Deficiencies Cited by FDA in 2014 By Alexander Gaffney, RAC - Published 08 December 2014

The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of pharmaceutical facilities, indicating the most common issues faced by pharmaceutical companies.

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

Tags: 483s, Form FDA 483, Form 483, 483 Trends, Pharmaceutical 483s, 483s Issued by FDA

'Questionable' Documentation Practices Lead FDA to Issue Form 483 to Biogen Idec By Alexander Gaffney, RF News Editor - Published 09 December 2013

Categories: US, FDA

Tags: Form 483, 483

Spiders, Non-Sterile Practices Lead to Warning for Compounder at Center of Recall By Alexander Gaffney, RF News Editor - Published 13 June 2013

Categories: US, FDA

Tags: Form 483, Compounding Pharmacy

Pharmaceutical Company's Regulatory Missteps Tempt Shareholder Legal Action By Alexander Gaffney, RF News Editor - Published 18 March 2013

Tags: Impax, Form 483, warning letter, Lawsuit

Judge: Regulatory Inspection Report Can Form Basis of Class Action Lawsuit By Alexander Gaffney - Published 05 June 2012

Categories: FDA

Tags: Shareholder, Ethex Corp., Hermelin, Inspection Report, Form 483, KV Pharmaceuticals, Lawsuit, Latest News