Common use of FDA Audits Clause in Contracts

FDA Audits. i. In the event of an FDA inspection which occurs as a result of this contract and for the product, or for any other FDA inspection that has the reasonable potential to impact the performance of this contract, the Contractor shall provide the CO and COR with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR) within five (5) business days after the Contractors receipt of those documents. The Contractor shall provide the COR and CO with copies of the plan for addressing areas of non- conformance to FDA regulations for GLP, GMP, or GCP guidelines as identified in the audit report, status updates during the plans execution and a copy of all final responses to the FDA. The Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. To the extent feasible, the Contractor shall make arrangements for BARDA representative(s) to be present during the final debrief by the regulatory inspector. ii. If draft documents are submitted to the COR for review, the COR will provide feedback to Contractor within 10 business days of receipt, or sooner as necessary to address FDA deadlines or requests. iii. If BARDA reviews draft documents, the Contractor shall revise as appropriate their submission. 1. Contractor shall notify CO and COR within 10 business days of a scheduled FDA audit or within 24 hours of an ad hoc site visit/audit advance notice. 2. Contractor shall provide copies of any FDA audit report received from subcontractors that occur as a result of this contract or for this product within 5 business days of receiving correspondence from the FDA, Subcontractor, or third party. 3. Within 15 business days of audit report, Contractor shall provide CO with a plan for addressing areas of nonconformance, if any are identified. Final FDA submissions shall be submitted to the CO and COR.

FDA Audits. i. In the event of an FDA inspection which occurs as a result of this contract and for the product, or for any other FDA inspection that has the reasonable potential to impact the performance of this contract, the Contractor shall provide the CO and COR COR/ACOR with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR) within five (5) business days after the Contractors receipt of those documents. The Contractor shall provide the COR COR/ACOR and CO with copies of the plan for addressing areas of non- non-conformance to FDA regulations for GLP, GMP, or GCP guidelines as identified in the audit report, status updates during the plans execution and a copy of all final responses to the FDA. The Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. To the extent feasible, the Contractor shall make arrangements for BARDA representative(s) to be present during the final debrief by the regulatory inspector. ii. If draft documents are submitted to the COR COR/ACOR for review, the COR COR/ACOR will provide feedback to Contractor within 10 business days of receipt, or sooner as necessary to address FDA deadlines or requests. iii. If BARDA reviews draft documents, the Contractor shall revise as appropriate their documents to address BARDA’s written concerns and/or recommendations prior to FDA submission. 1. Contractor shall notify CO and COR COR/ACOR within 10 business days of a scheduled FDA audit or within 24 hours of an ad hoc site visit/audit if the FDA does not provide 10 business days’ advance notice. 2. Contractor shall provide copies of any FDA audit report received from subcontractors that occur as a result of this contract or for this product within 5 business days of receiving correspondence from the FDA, Subcontractor, or third party. 3. Within 15 business days of audit report, Contractor shall provide CO with a plan for addressing areas of nonconformance, if any are identified. Final FDA submissions shall be submitted to the CO and COR.

FDA Audits. i. In the event of an FDA inspection which occurs as a result of this contract and for the product, or for any other FDA inspection that has the reasonable potential to impact the performance of this contract, the Contractor shall provide the CO and COR with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR) within five (5) business days after the Contractors receipt of those documents. The Contractor shall provide the COR and CO with copies of the plan for addressing areas of non- non-conformance to FDA regulations for GLP, GMP, or GCP guidelines as identified in the audit report, status updates during the plans execution and a copy of all final responses to the FDA. The Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. To the extent feasible, the Contractor shall make arrangements for BARDA representative(s) to be present during the final debrief by the regulatory inspector. ii. If draft documents are submitted to the COR for review, the COR will provide feedback to Contractor within 10 business days of receipt, or sooner as necessary to address FDA deadlines or requests. iii. If BARDA reviews draft documents, the Contractor shall revise as appropriate their documents to address ▇▇▇▇▇’s written concerns and/or recommendations prior to FDA submission. 1. Contractor shall notify CO and COR within 10 business days of a scheduled FDA audit or within 24 hours of an ad hoc site visit/audit if the FDA does not provide 10 business days’ advance notice. 2. Contractor shall provide copies of any FDA audit report received from subcontractors that occur as a result of this contract or for this product within 5 business days of receiving correspondence from the FDA, Subcontractor, or third party. 3. Within 15 business days of audit report, Contractor shall provide CO with a plan for addressing areas of nonconformance, if any are identified. Final FDA submissions shall be submitted to the CO and COR.