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Posts Tagged ‘Inspections’

New sources of FDA enforcement information posted

May 26, 2011 31 comments

Today, the FDA is implementing the first in a series of proposals to increase public understanding of the public health impact of FDA’s enforcement efforts, help inform companies’ efforts to comply with FDA requirements, increase company accountability to consumers and business partners, and help consumers make more informed decisions about the products they buy.

This action stems directly from the FDA Transparency Initiative, which Commissioner Margaret A. Hamburg, M.D. launched in 2009. The initiative is designed to examine all agency activities and consider ways to make them more transparent. After holding public meetings and inviting written comments, FDA issued its first report, proposing 21 actions to increase disclosures about agency activities.  Today, the agency is taking several steps to increase transparency related to its enforcement activities:

• Posting a summary of the most common inspectional observations of objectionable conditions or practices that are made during inspections.

• Providing a searchable database that includes the name and address of inspected facilities, the date(s) of inspection, type of FDA-regulated products involved, and final inspectional classification.

• Alerting the public in a consistent manner about enforcement actions, by issuing press at the beginning and the end of the process, unless confidentiality is necessary.

The FDA is also providing a new web page to house all of the agency’s key transparency activities related to enforcement so that these resources will be easier to find and use.

In the coming months, 3 additional enforcement-related transparency actions will be implemented. FDA will begin to disclose additional information about FDA evaluations of importers, expand disclosure of Untitled Letters, and in appropriate situations, support industry efforts during a food recall to inform consumers of products that are not subject to the recall. FDA will also move forward on other proposals in the report.

Ann Witt
Transparency Coordinator

Upcoming Event: FDA Basics Webinar on Foreign Inspections, May 17, 2011, at 12:30pm ET

May 12, 2011 26 comments

Did you know that FDA foreign inspections have doubled since 2008? Did you know that foreign food inspections alone have quadrupled since 2010?

As part of FDA Basics, FDA is hosting a webinar on foreign inspections where you can learn more. Susan Laska, the Deputy Director of the Division of Foreign Field Investigations, will give an overview and answer questions about FDA’s Global Inspection program.

The free 30 minute webinar will be held Tuesday May 17, 2011 at 12:30 pm ET.

There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA website following the presentation.

Learn more about the webinar, including instructions about how to join the webinar.

Ann Witt, Transparency Initiative Coordinator

FDA’s Center for Devices and Radiological Health (CDRH) Launches Inspections Database

October 1, 2010 7 comments

Yesterday, as part of the FDA Transparency Initiative, CDRH launched the ‘CDRH Inspections Database’.  The database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present (approximately 25% of the medical device inspections conducted since 2008).  The database contains information about the firms, types of devices and inspections, and links to warning letters (when available).

You can search the inspection database by various parameters, including company name, inspection type, product code, inspection classifaction, inspection action, and date.  You can find the database here.

We encourage your feedback on the database and welcome your suggestions for additional information you would like to see.  You can provide feedback on the FDA Web site.

Afia Asamoah, Transparency Initiative Coordinator

Upcoming Events: FDA Basics Webinar on the Inspection Process, March 25, 2 p.m. ET

March 22, 2010 55 comments

What kinds of products and facilities does the Food and Drug Administration (FDA) inspect? Who conducts these inspections?  What do they look for?

As part of FDA Basics, FDA is hosting a webinar where you can learn more about FDA’s inspection process.  The featured speaker, Michael Rogers, Deputy Director, Office of Regional Operations, will discuss how FDA staff inspect domestic and foreign establishments, check shipments of imported product, and collect and test samples for signs of contamination.  There will be time for questions following the presentation.

The free 30 minute webinar will be held on Thursday, March 25, at 2 p.m. ET.

You can find out more information about the webinar, including how to participate in the webinar on the FDA Basics homepage.  Click here for more information about the webinar.

Afia Asamoah

Transparency Initiative Coordinator

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