FDA 483 - Compound Preferred LLC - August 01, 2019

This FDA Form 483 details significant deficiencies at RAM Pharma, Inc., an outsourcing facility in Idaho Falls, ID, following an inspection from July 16 to August 1, 2019. The observations primarily concern severe lapses in aseptic processing, environmental monitoring, process validation, stability testing, and quality control for sterile drug products. Repeated microbial contamination, lack of critical testing, and inadequate investigations indicate a high risk of product contamination and compromised quality.