§1.1153. What are the requirements for submitting abridged analytical reports? — Inbound Citations

(c) The following documentation must be included with each full analytical report (see paragraph (d) of this section) and each abridged analytical report (see § 1.1153) submitted to FDA under this subpart:

(1) All sampling plans and sample collection reports related to the food testing conducted as developed or obtained by the LAAF-accredited laboratory in accordance with § 1.1149;

(2) Written documentation of the sampler's qualifications or an indication that the sampler's qualifications have been submitted previously, in accordance with § 1.1149(a)(1);

(3) For any validation studies required by § 1.1151(c)(1), the documentation required by § 1.1151(c)(2);

(4) For any verification studies required by § 1.1151(d)(1), the documentation required by § 1.1151(d)(2);

(5) The justification for any modification to or deviation from the method(s) of analysis used and documentation of the LAAF-accredited laboratory's authorization for the modification or deviation; and

(6) A certification from one or more members of the LAAF-accredited laboratory's management certifying that the test results, notifications, reports, and studies are true and accurate; and that the documentation includes the results of all tests conducted under this subpart. The certification must include the name, title, and signature of any certifiers.

(3) All documents that the LAAF-accredited laboratory was required to submit to FDA under §§ 1.1152 and 1.1153, and associated correspondence between the LAAF-accredited laboratory (and its officers, employees, and other agents) and the owner or consignee (and its officers, employees, and other agents) regarding food testing under this subpart;

(2) Revoke permission to submit abridged reports for that major food testing discipline under § 1.1153(b);

(2) 2017(E), General requirements for the competence of testing and calibration laboratories, Third edition, November 2017, IBR approved for §§ 1.1120(c), 1.1121(a), 1.1138(a), 1.1139(b) and (c), 1.1141(a), 1.1152(a) and (d), 1.1153(c), and 1.1161(a).