Regulatory Response
Board of Pharmacy | FDA | 483 | Warning | Accusation | Plan of Correction
If you've received a 483, a warning letter, accusation or corrective action mandate, you’re on the clock—and the stakes are high.
We bring real-world experience from inside 503A, 503B, and GMP-regulated facilities to help you respond quickly, effectively, and credibly. We work with your team to investigate root causes, draft clear and compliant responses, and implement practical solutions that demonstrate control.
We’ve helped compounders and manufacturers turn around difficult inspections and enforcement actions—so you can move forward with confidence and get back to what matters: making safe, high-quality drugs.