bio_subbu
Super Moderator
Dear All
The US FDA is proposing a new user fee to require any of the drug and device establishments that it inspects to pay the full costs of reinspections and associated follow-up work.
According to the FDA 2011 Budget Proposal, the Agency is planning to impose the user fee when it reinspects facilities following a failure to meet Good Manufacturing Practices (GMPs) or other FDA requirements. When FDA identifies violations during an inspection or issues a warning letter following an inspection, it conducts follow-up inspections to verify that the problem was corrected. FDA procedures usually require that FDA conducts a follow-up inspection of the firm within 90 days of issuing a warning letter.
The proposed Re-inspection user fee will ensure that facilities which fail to comply with the necessary standards bear the cost of the re-inspection.
A copy of full FDA budget proposal can be accessed from (broken link removed)Regards
S. Subramaniam
The US FDA is proposing a new user fee to require any of the drug and device establishments that it inspects to pay the full costs of reinspections and associated follow-up work.
According to the FDA 2011 Budget Proposal, the Agency is planning to impose the user fee when it reinspects facilities following a failure to meet Good Manufacturing Practices (GMPs) or other FDA requirements. When FDA identifies violations during an inspection or issues a warning letter following an inspection, it conducts follow-up inspections to verify that the problem was corrected. FDA procedures usually require that FDA conducts a follow-up inspection of the firm within 90 days of issuing a warning letter.
The proposed Re-inspection user fee will ensure that facilities which fail to comply with the necessary standards bear the cost of the re-inspection.
A copy of full FDA budget proposal can be accessed from (broken link removed)Regards
S. Subramaniam
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