How compliant is your supplier? FDA establishes new Online Inspection Database

On May 26, 2011 the U.S. Food and Drug Administration announced a new web portal on its inspection activities. A key element of this new web portal is a searchable Inspections Database that includes the names and addresses of inspected facilities, inspection dates, type of FDA-regulated products involved, and final inspectional classification.

The new information available now has been triggered by the FDA Transparency Initiative. In the second phase of the initiative a total of 21 proposals have been published, among them some proposals to disclose information about enforcement actions and inspections performed. As a consequence the information which is now available on the new web portal includes a summary of the most common Inspectional Observations of objectionable conditions or practices made during inspections.

Here you can access the inspection database.

By using the database one can easily find any company that has been inspected by FDA and receives information about the inspection outcome. This tool will also help industry because relevant information about suppliers of APIs as well as information about contract manufactures can be accessed in seconds.

So far only Warning Letters have been published on the webpage. With this new initiative observations from the so-called Form 483 will also be published. The Form 483 is filled out during the inspection and contains observations identified by the investigator. The format of any single observation begins with a statement based in a citation of law, regulation or Act and is followed by a statement of specific conditions observed during the inspection. At the moment not all 483 Forms have been published, but a larger number of documents (frequently requested via FOI).

Here you can find the 483-Forms.

Spreadsheets summarizing the areas of regulation cited on FDA's system-generated 483s are available by fiscal year. These Speadsheets contain the area of regulation and the number of times it was cited as an observation on an FDA Form 483 during inspections conducted by FDA.

To make it easier to navigate in the comprehensive data the FDA structured the information into the following areas

• Biologics 
• Foods (includes Dietary Supplements) 
• Drugs 
• Veterinary Medicine 
• Devices 
• Bioresearch Monitoring 
• Human Tissue for Transplantation 
• Special Requirements 
• Radiological Health 
• Total number of inspections and 483s 
• Parts 1240 and 1250

In addition you can access the information about the 2010 Inspectional Observation summaries.

Also interesting are the FDA enforcement Statistics, e.g. the summary of the Fiscal Year 2010 activities.

Summarized by Oliver Schmidt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

Source: FDA Press Release