§1.1124. What are the records requirements for a recognized accreditation body? — Inbound Citations

(f) Within 10 business days of the date of FDA's issuance of a denial of an application for renewal of recognition, the applicant must provide the name and contact information of the custodian who will maintain required records and make them available to FDA under § 1.1124. The contact information must include an email address for the records custodian and the street address where the records required under § 1.1124 will be located.

(a) At least 60 calendar days before voluntarily relinquishing its recognition or before allowing its recognition to expire without seeking renewal, a recognized accreditation body must notify FDA of its intention to leave the program, specifying the date on which the relinquishment or expiration will occur. The recognized accreditation body must provide the name and contact information of the custodian who will maintain and make available to FDA the records required by § 1.1124 after the date of relinquishment or the date recognition expires, as applicable. The contact information must include an email address for the records custodian and the street address where the records required under § 1.1124 will be located.

(3) Within 10 business days of the date of issuance of revocation, the accreditation body must provide the name and contact information of the custodian who will maintain records and make them available to FDA as required by § 1.1124. The contact information must include an email address for the records custodian and the street address where the records required by § 1.1124 will be located.