21 CFR § 1.1123 - What reports, notifications, and documentation must a recognized accreditation body submit to FDA?

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

(a) General requirements. All reports and notifications required by this section must include:

(1) The name, street address, telephone number, and email address of the recognized accreditation body associated with the report or notification, and the name of an appropriate point of contact for the recognized accreditation body, and

(2) If the report or notification concerns a LAAF-accredited laboratory, the name, street address, telephone number, and email address of the LAAF-accredited laboratory, and the name of an appropriate point of contact for the LAAF-accredited laboratory.

(b) Internal audit reports. A recognized accreditation body must submit to FDA a report of the results of the internal audit conducted pursuant to § 1.1125 within 45 calendar days of completing the audit. The audit report must include:

(1) A description of the internal audit conducted;

(2) A description of any identified deficiencies;

(3) A description of any corrective action taken or planned, including the timeline for such corrective action; and

(4) A statement disclosing the extent to which the internal audit was conducted by personnel different from those who perform the activity or activities that were audited.

(c) Changes affecting recognition. A recognized accreditation body must notify FDA within 48 hours when the recognized accreditation body is aware of a change that would affect the recognition of such accreditation body, and the notification must include:

(1) A description of the change, and

(2) If the change is one made by the recognized accreditation body, an explanation of the purpose of the change.

(d) Changes in LAAF-accreditation. A recognized accreditation body must notify FDA and submit a certificate reflecting the scope of accreditation within 48 hours when any of the following occur:

(1) The recognized accreditation body grants or extends LAAF-accreditation of a laboratory, and the notification must include:

(i) The scope of LAAF-accreditation requested by the laboratory,

(ii) The scope of LAAF-accreditation granted, and

(iii) The effective date of the grant or extension;

(2) The recognized accreditation body denies LAAF-accreditation of a laboratory, and the notification must include:

(i) The scope of LAAF-accreditation requested by the laboratory,

(ii) The scope of LAAF-accreditation denied, and

(iii) The grounds for the denial;

(3) The recognized accreditation body receives notice that a laboratory it LAAF-accredits intends to relinquish its LAAF-accreditation and the laboratory has not provided notice to FDA 60 calendar days prior to relinquishment as required under § 1.1140. The recognized accreditation body's notification must include:

(i) The scope of LAAF-accreditation to which the relinquishment applies, as applicable, and

(ii) The effective date of the relinquishment;

(4) The recognized accreditation body reduces the scope of or withdraws the LAAF-accreditation of a laboratory, and the notification must include:

(i) The scope of LAAF-accreditation to which the reduction applies,

(ii) The grounds for the reduction of scope or withdrawal, and

(iii) The effective date of the reduction of scope or withdrawal;

(5) The recognized accreditation body suspends or lifts the suspension of a LAAF-accredited laboratory, and the notification must include:

(i) The scope of LAAF-accreditation to which the suspension applies,

(ii) The grounds for the suspension or for lifting the suspension, and

(iii) The effective date of the suspension or date the suspension is lifted.

(e) Laboratory fraud. A recognized accreditation body must notify FDA within 48 hours if the recognized accreditation body knows that a laboratory it LAAF-accredits has committed fraud or submitted material false statements to FDA, and the notification must include:

(1) A description of the basis for the recognized accreditation body's knowledge of the fraud or material false statements,

(2) A description of the fraud or material false statements, and

(3) The action(s) taken by the recognized accreditation body with respect to such LAAF-accredited laboratory.

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