Preparing for Inspection

Related Pages

The Federal Select Agent Program has posted inspection checklists to assist entities with preparing for an inspection.

Please also view the SA Gram dated July 19, 2012 for more information regarding FSAP’s policy on verifying inspectors and an entity’s request to sign a confidentially agreement.

Inspection Checklists

To ensure that entities are complying with the requirements of the select agent regulations, the Federal Select Agent Program (FSAP) inspects entities using standardized checklists to certify that laboratories have the appropriate safety and security measures in place. These checklists are designed based on provisions outlined in the select agent regulations and nationally recognized standards (e.g., Biosafety in Microbiological and Biomedical Laboratories (BMBL) and NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules).

The inspection checklists can be downloaded below to support inspection preparation and ongoing compliance; these updates reflect the most current versions already used during inspections.

Regulatory Checklists