
Responding to FDA 483s: Do’s, Don’ts, and When to Call In a Remediation Partner
February 14, 2014
Lisa Weeks, Marketing Communications, MasterControl Inc.
Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to your company's survival. Having a sound quality management system in place is critical, but when remedial action is necessary, time is of the essence. After all, you have only 15 working days from the receipt of the 483 to respond!
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