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Alternatively, during any subsequent inspection, FDA investigators are expected to verify overall completeness and effectiveness of corrective actions (because of the Warning Letter). The timing of a subsequent investigation may be expedited or routine, as determined by the issuing office. Should violations be observed during a subsequent inspection or through other means, enforcement actions may be taken without further notice. As was previously mentioned, additional enforcement actions available to FDA to achieve correction are product recall, seizure, injunction, administrative detention, civil money penalties and/or prosecution.
In the next issue, we will address The Anatomy of a Warning Letter, Part Two: Excerpts and Response Strategies.
REFERENCE
Inspections, Compliance, Enforcement, and Criminal Investigations. More information and most recently-posted Warning Letters. www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
John Gagliardi has had success over the past 40 years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. John specializes in building systems in a compliant and business-ready manner. Email John at JGAGL777@One.Net.
MidWest Process Innovation, LLC
513-573-0085 (phone)
www.midwestprocessinnovation.com
