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Posts By: Mary Kamm, John Lowe and Jeni Britton Bauer

A joint blog post from our Quality Leader, CEO, and Jeni

We received a Warning Letter from the FDA following their January inspection of our facility. We are happy to get to the next stage with the FDA, and we appreciate that the FDA went to the unusual step of noting in the letter the significant work and changes we made since we first learned of a…