FDA issues revised site selection model tying surveillance inspections to location

The US Food and Drug Administration (FDA) recently issued an internal Manual of Policies and Procedures (MAPP) for its staff outlining how it will prioritize inspections under its site selection model (SSM) for routine quality related surveillance inspections. The update adds a risk factor for establishments located in countries where there is a “history of violations” related to exports.

The update revises a previous version issued in September 2018 to add a “risk factor for establishments related to the compliance history of establishments in the country or region in which an establishment is located.” This can include “the history of violations related to products exported from such country or region that are subject to such regulation.” (RELATED: FDA reveals how manufacturing facilities are prioritized for inspections, Regulatory Focus 5 September 2018).

The update was tied to an amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by section 510(h)(4) by the Food and Drug Omnibus Reform Act of 2022 (FDORA).

The update also provides more clarity on the risk factors associated with patient exposure and inherent product risk, adds language about quality system effectiveness, and changes the name of the Office of Pharmaceutical Quality (OPQ) suboffice from the “Office of Surveillance” to the “Office of Quality Surveillance (OQS).”

The following are considered risk factors and included in the site selection model: the site type, time since last surveillance inspection, FDA compliance history, compliance history of the country or region, foreign regulatory authority inspectional history, patient exposure and hazard signals such as Field Alert Reports, Biological Product Deviation Reports, MedWatch reports and recalls.

FDA also considers other “inherent” risk in its site section models, including the dosage form, route of administration, sterile products, active pharmaceutical load (API) load or the concentration of API in dosage form or unit dose, therapeutic class, whether the drug has a narrow therapeutic index and whether the drug is used for emergencies.

Sites that are excluded from the site selection model include human drug compounding outsourcing facilities registered under section 503B of the FD&C Act, medical gas sites, inactive ingredients or excipients or drugs intended for use only in clinical trials.

The MAPP further states that FDA’s Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) must annually review and approve changes to the site selection model every year.

According to the MAPP, FDA has used this risk-based approach for prioritizing human drug inspections since fiscal year (FY) 2005. It replaces the former model of inspecting sites every two years.

FDA

FDA issues revised site selection model tying surveillance inspections to location

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