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Inspections - Draft Proposal 6

View PDF of the Inspections Section (49KB)


Background

Summary of Public Comments

Considerations

View All Inspections Draft Proposals

View Comments for this Proposal


Average Rating for this proposal (Based on 7 Ratings):
star ratingstar ratingstar ratingTransparency Report Half Star

Draft Proposal
FDA should disclose the name and address of the entity inspected, the date(s) of inspection, type(s) of FDA-regulated product involved, and the final inspectional classification—Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI)—for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed.  The disclosure of this information should be timed so as not to interfere with planned enforcement actions.

 

Reasoning: Disclosing information about the findings from establishment inspections increases public understanding about some of the ways FDA works to protect the public health.  Disclosure of FDA’s determination about the compliance status of establishments provides the public with a basis and rationale for enforcement actions FDA pursues against an establishment.

Public disclosure of this information makes firms accountable not only to FDA, but to the public at large.  Disclosure of inspectional classification information may serve as an incentive to firms to correct violations. 

Further, other firms are provided with information that will help them make more informed decisions about companies they choose to do business with.  If FDA, for example, has concluded that a distributor has had significant objectionable conditions at its facility, this is important information to convey to manufacturers, schools, federal agencies, and other entities that may contract with that distributor.  Market pressures may create incentives for firms to correct violations quickly or prevent violations from occurring in the future.


Comments for this proposal 

(Total Received: 6)

Comment: Inspection results should be easily accessible along with corrective actions taken if any. A report could be done once a year the identified the worst problems found and most common problems found and what has been done to eliminate or reduce them. It is important for the public to be informed on the safety of drug manufacturing facilities, human blood and tissue collection and distribution, and livestock packing plants.
Date Submitted: 5/22/2010
Comment: This proposal will allow the allow establishments to more readily evaluate their operations in a timely manner, if this information is made available at lease on a semi-annual basis. jehamilton&associates
Date Submitted: 6/17/2010
Comment: Very good proposal!
Date Submitted: 7/17/2010
Comment: CRN agrees that obtaining inspection information through the FOIA process is time  consuming, inconsistent, and in need of improvement. CRN supports the disclosure of the proposed information outlined in Draft Proposal 6. However, the disclosure of the information should not interfere with a planned enforcement action, and the agency should not release any inspection information until after all proprietary or confidential information has been redacted. The FDA conducted approximately 14,800 inspections in FY 2008 and has indicated that additional funding will allow for more inspections in the future. The agency resources that will be required to post the results of inspections in a timely manner should not come at the expense of resources necessary for conducting inspections. The FDA started inspecting dietary supplement facilities in 2008 and has only inspected a small fraction of the existing facilities. CRN members urge the FDA to assign higher priority to conducting inspections of
Date Submitted: 7/19/2010
Comment: The FDA started inspecting dietary supplement facilities in 2008 and has only inspected a small fraction of the existing facilities. CRN members urge the FDA to assign higher priority to conducting inspections of dietary supplement facilities rather than summarizing the findings for the public
Date Submitted: 7/19/2010
Comment: OMB Watch, a nonprofit, nonpartisan research and advocacy organization, supports this proposal. FDA should release detailed information on inspections of any facility in FDA’s jurisdiction, both foreign and domestic. FDA should also provide detailed information on any corrective actions taken by the facility and/or ordered by the agency, and any punitive actions, such as fines. FDA should indicate the status of these actions. In addition to providing detailed information on a facility-by-facility basis, FDA should provide summary information, such as total number of inspections in a certain time period or certain geographic location, or total amount of fines assessed and/or collected by the agency
Date Submitted: 7/19/2010