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15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.
42 FR 15553, Mar. 22, 1977, unless otherwise noted.
86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022, unless otherwise noted.
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(a) In addition to meeting the requirements of § 1.1113(a) related to records, a recognized accreditation body must maintain, for 5 years after the date of creation of the records, records created while it is recognized demonstrating its compliance with this subpart, including records relating to:
(1) Applications for LAAF-accreditation;
(2) Assessments, reassessments, and decisions to grant, extend the scope of, renew, deny, reduce the scope of, or withdraw LAAF-accreditation or to suspend or lift the suspension of a LAAF-accredited laboratory;
(3) Appeals of suspensions, denials, reductions of scope of, and withdrawals of LAAF-accreditation, final decisions on such appeals, and the bases for such final decisions;
(4) Its oversight of laboratories it has LAAF-accredited;
(5) Its oversight of its own performance, including all records related to internal audits, complaints, and corrective actions;
(6) Any reports or notifications required to be submitted to FDA under § 1.1123, including any supporting information;
(7) Records of fee payments and reimbursement of direct costs; and
(8) Any documents demonstrating compliance with the requirements for assessment activities by contract assessors with certain financial interests described in § 1.1119(d).
(b) A recognized accreditation body must make the records it is required to maintain by paragraph (a) of this section available for inspection and copying or for electronic submission upon written request of an authorized officer or employee of FDA. If FDA requests records for inspection and copying, the recognized accreditation body must make such records promptly available at the physical location of the recognized accreditation body or at another reasonably accessible location. If FDA requests electronic submission, the records must be submitted within 10 business days of the request.
(c) A recognized accreditation body must not prevent or interfere with FDA's access to the records the LAAF-accredited laboratories it LAAF-accredits are required to maintain under § 1.1154.