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Inspections - Draft Proposal 7

View PDF of the Inspections Section (49KB)


Summary of Public Comments


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View Comments for this Proposal

Average Rating for this proposal (Based on 8 Ratings):
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Draft Proposal
FDA should generate, and share with the public, information about the most common inspectional observations of objectionable conditions or practices that are made during inspections of FDA-regulated establishments and post that information online on a regular basis.

Reasoning: FDA should disclose summary information about common violations associated with FDA-regulated products; this is a method to provide firms with information that can be used to inform compliance efforts.

Comments for this proposal 

(Total Received:4)

Comment: It is critical that the people know that packing plants, and drug manufacturing plants as well as facilities that collect and distribute human blood and tissue products are as safe and clean as possible. The public also should know any problems that were found and what is being done to correct them. This information should be accessible to screen readers and be in large print format.
Date Submitted: 5/22/2010
Comment: CRN strongly supports the Draft Proposal 7. Sharing with the public information about the most common inspectional violations will provide firms with valuable information to inform compliance efforts. Currently, companies use significant resources to obtain inspection information through the FOIA process, analyze this information, and search for clues to aide in compliance efforts. Draft proposal 7 would allow these firms to focus e resources on actual compliance efforts.
Date Submitted: 7/19/2010
Comment: OMB Watch, a nonprofit, nonpartisan research and advocacy organization, supports this proposal. FDA should provide information on common hazards and violations in order to better inform the public of the risks posed by FDA-regulated products and the agency’s efforts to prevent or abate those risks. Public protections, such as those FDA enforces, are critical to public health, and the FDA has a responsibility to educate the public about the important work it conducts.
Date Submitted: 7/19/2010
Comment: This is important information, as long as it's a summary and does not disclose any infomration about specific plants/companies.
Date Submitted: 7/20/2010