Idaho Outsourcer Cited for Repeat Violations

The FDA hit RAM Pharma, a drug compounding and outsourcing firm, for numerous failures at its Idaho Falls facility, including repeat findings of microbial growth and lax air sampling.

Agency investigators found the facility had inadequate environmental monitoring and the firm’s  testing records for finished product sterility testing showed approximately 15 samples with microbial growth. But the firm failed to take steps to ward off possible drug product contamination.

The firm also failed to conduct air sampling during production or potency testing for any finished drug products before distribution and it had no systems in place to catch potential gaps in air quality.

The investigation also revealed new violations. For example, the firm failed to validate processes for the removal of pyrogens — fever-producing chemicals — from sterile glassware used in the production of high-risk sterile drug products and not all sterile drug products were tested to ensure they did not contain pyrogens.