By Susan Shockey, Clarkston Consulting

Published in: Outsourced Pharma

Published on: September 1, 2023

How you respond to the observations will determine if they escalate into more serious consequences, such as a warning letter or enforcement action. A review of published warning letters confirms that a significant percentage could have been avoided by a proper response to the Form 483. Our goal is to help you take appropriate actions to optimize the outcome after receipt of FDA observations.

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