Search Results for CAPA

Showing 1 – 9

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 Warns Three Device Companies From US, Germany and France, One Indian API Manufacturer By Zachary Brennan - Published 25 October 2017

The US Food and Drug Administration (FDA) this week released three warning letters sent to medical device manufacturers, including Florida-based UVLrx Therapeutics, Inc., Germany-based DRG Instruments GmbH and France-based ELITech Group SAS, as well as one to Vapi, India-based active pharmaceutical ingredient (API) manufacturer Vital Laboratories.

Categories: News, Asia, Europe, US, FDA, Active pharmaceutical ingredients, Compliance, Manufacturing, Medical Devices

Tags: warning letters, ELISA, CAPA

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 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

CDRH Increases Foreign Quality System Inspections By Zachary Brennan - Published 05 November 2015

Although the number of quality system surveillance inspections only rose slightly between 2013 and 2014 overall, the number of such inspections for foreign manufacturers increased by nearly 30%, according to new data released by the FDA’s Center for Devices and Radiological Health (CDRH).

Categories: News, Asia, US, CDRH, Compliance, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Quality

Tags: CDRH, quality system, device inspections, CAPA

Creating a Culture of Compliance By Susan Mozgai and David Lerner - Published 21 May 2014

In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.

Categories: Features, Compliance, Quality

Tags: CAPA, Continuous Improvement, QMS, Quality Management System

Medical Device Corrective and Preventive Actions By Devin McBlair - Published 11 July 2013

Medical device companies are required by law to have corrective and preventive action (CAPA) procedures to identify, prevent and correct product quality nonconformities. The effectiveness of a CAPA procedure can make the difference between successfully resolving deficiencies and enduring recurring deficiencies that result in waste, inefficiency, customer dissatisfaction and, potentially, patient-related adverse events.

Categories: US, FDA

Tags: Quality and Compliance, CAPA, medical device

Rare Multi-Facility Warning Letter Slams Manufacturer, Says Concerns Extend to All Plants By Alexander Gaffney, RF News Editor - Published 20 March 2013

Categories: Canada, FDA

Tags: Apotex, warning letter, Latest News, cGMP, process validation, CAPA

Alleged Sterility Deficiencies Behind Warning Letter to Medical Device Company By Alexander Gaffney, RF News Editor - Published 01 November 2012

Categories: FDA

Tags: Atrium, Sterility, warning letter, Latest News, CAPA, medical device