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Re: jcon777 post# 3518

Wednesday, 04/28/2021 6:57:52 AM

Wednesday, April 28, 2021 6:57:52 AM

Post# of 3999
Interesting, this article also shows outsourced manufacturing as a common cause of CRLs.

From 2017.

https://cen.acs.org/articles/95/i20/complete-response-letter-mail-one.html

Such issues would also be more likely to reflect "We are continuing to coordinate closely with the FDA to address and quickly resolve the deficiencies contained in the CRL."
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