Title 21

SECTION 1.625

1.625 What records requirements must an accreditation body that has been recognized meet

§ 1.625 What records requirements must an accreditation body that has been recognized meet?

(a) An accreditation body that has been recognized must maintain electronically for 5 years records created while it is recognized (including documents and data) demonstrating its compliance with this subpart, including records relating to:

(1) Applications for accreditation and renewal of accreditation under § 1.660;

(2) Decisions to grant, deny, suspend, withdraw, or expand or reduce the scope of an accreditation;

(3) Challenges to adverse accreditation decisions under § 1.620(c);

(4) Its monitoring of accredited third-party certification bodies under § 1.621;

(5) Self-assessments and corrective actions under § 1.622;

(6) Regulatory audit reports, including any supporting information, that an accredited third-party certification body may have submitted;

(7) Any reports or notifications to FDA under § 1.623, including any supporting information; and

(8) Records of fee payments and reimbursement of direct costs.

(b) An accreditation body that has been recognized must make records required by paragraph (a) of this section available for inspection and copying promptly upon written request of an authorized FDA officer or employee at the place of business of the accreditation body or at a reasonably accessible location. If the records required by paragraph (a) of this section are requested by FDA electronically, the records must be submitted to FDA electronically not later than 10 business days after the date of the request. Additionally, if the requested records are maintained in a language other than English, the accreditation body must electronically submit an English translation within a reasonable time.

(c) An accreditation body that has been recognized must not prevent or interfere with FDA's access to its accredited third-party certification bodies and the accredited third-party certification body records required by § 1.658.

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