503A Pharmacies: The FDA has designated 503A compounding pharmacies as those that compound according to prescriptions specific to patients and are required to comply with USP and state requirements. Compounding pharmacies continue to receive intense scrutiny from the State Board of Pharmacies and the FDA.
As a result, 503A pharmacies are experiencing inspections from the FDA, 483s, Warning Letters and in some cases closures. Biomed Innova seeks to provide quality support, assistance with FDA’s 483s and Warning Letters, raw material testing, assays, sterility and endotoxin testing.
- Ph Tests
- Regulatory and cGMP Support