What can Outsourcing Facilities (503B Facilities) expect as part of their on-site review during a Supply Chain Inspection?
For a Supply Chain Inspection, NABP typically sends two inspectors, one of whom is a pharmacist who will evaluate compounding aseptic principles. The inspectors are not specifically looking for full compliance with USP <797> or cGMP but looking at common themes for compounding facilities such as facility design and control; compounder/operator training, aseptic technique, garbing; cleaning; equipment; certification reports; master formulation records, batch reports and/or compounding records; visual observation program, release testing; and labeling. This is not an all-inclusive list but are examples to assist the applicant in the types of compounding related activities our inspector(s) will review during the onsite inspection. A Supply Chain Inspection does not confirm compliance with USP <795>, <797>, or <800> or with cGMPs. We defer to the entity’s FDA Establishment Inspection Report (EIR) for compliance with cGMPs. If observations are described in an open FDA Form 483 or Warning Letter, the applicant can expect the NABP inspector(s) to ask specific questions on how the facility is working with FDA to address these items and, in some cases, evidence during the inspection these are resolved (or the applicant is working towards resolution).