Common Filing Issues Persist Despite Faster FDA Processing Times in ACE, FDA Official Says
ACE has resulted in faster processing times for imports regulated by the Food and Drug Administration, but some filing issues persist, FDA import director Douglas Stearn said in a July 31 blog post. The proportion of entry lines receiving an…
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automated “may proceed” has increased from 26 percent to 62 percent since adoption of the new system, and 28,374 fewer entry lines have needed additional documents and information. But a study of FDA rejections between November 2016 and March 2017 found that the most common filing problems were the submission of invalid or canceled food facility registration numbers and invalid FDA product codes, Stearn said. Other common filing issues may cause an entry to be rejected before ever making it to FDA for review, including incorrect syntax or omission of required affirmations of compliance, missing or invalid entity information, and missing or invalid units of measure, he said.