§1.1123. What reports, notifications, and documentation must a recognized accreditation body submit to FDA? — Inbound Citations

(6) Any reports or notifications required to be submitted to FDA under § 1.1123, including any supporting information;

(f) The LAAF-accredited laboratory must notify FDA and the recognized accreditation body that LAAF-accredited the laboratory of changes that affect the LAAF-accreditation of the laboratory within 48 hours, including a detailed description of such changes, and an explanation of how such changes affect the LAAF-accreditation of the laboratory. LAAF-accredited laboratories are not required to notify FDA of changes that a recognized accreditation body must provide to FDA under § 1.1123(d).

(2) The recognized accreditation body must notify FDA of the reduction of scope or withdrawal of LAAF-accreditation under this section in accordance with the requirements in § 1.1123(d)(4). FDA will provide notice of the reduction of scope or withdrawal of the laboratory's LAAF-accreditation on the website described in § 1.1109.

(2) The recognized accreditation body must notify FDA of the suspension under this section in accordance with the requirements of § 1.1123(d)(5). FDA will provide notice of the LAAF-accredited laboratory's suspension on the website described in § 1.1109.