Change of manufacturing site: import source cancelled; applicants must treat that supplier as new registration requiring data submission. The Registration Committee found the manufacturer failed to notify a change of location of the manufacturing site and did not provide the required 5-Batch samples from old and new sites for impurity verification; as samples from the old plant are unavailable, the Committee cancelled the import source designation and directed that future applicants treat the source as a new registration with requisite data submissions and testing.
Cases where this provision is explicitly mentioned in the judgment/order text; may not be exhaustive. To view the complete list of cases mentioning this section, Click here.
Provisions expressly mentioned in the judgment/order text.
Change of manufacturing site: import source cancelled; applicants must treat that supplier as new registration requiring data submission.
The Registration Committee found the manufacturer failed to notify a change of location of the manufacturing site and did not provide the required 5-Batch samples from old and new sites for impurity verification; as samples from the old plant are unavailable, the Committee cancelled the import source designation and directed that future applicants treat the source as a new registration with requisite data submissions and testing.
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