Instant Download | Analysis of 2021 U.S. FDA 483 GMP Observations
A comprehensive GMP intelligence program includes monitoring health authority enforcement actions including U.S. FDA forms 483, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, MHRA annual summaries of inspection deficiencies, and EU reports of GMDP noncompliance. In addition to enforcement actions, a comprehensive program includes monitoring new or revised laws, regulations and […]