§1.1152. What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA? — Inbound Citations

(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) 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).

(a) Before analyzing a sample, the LAAF-accredited laboratory must develop (if it collected the sample) or obtain (if another firm collected the sample) the following information to be submitted with test results (see § 1.1152(c)):

(1) A LAAF-accredited laboratory only needs to develop or obtain documentation of a sampler's qualifications the first time that sampler collects a sample for the LAAF-accredited laboratory under this subpart. If a LAAF-accredited laboratory has previously submitted the sampler's qualifications to FDA under § 1.1152(c), the LAAF-accredited laboratory may refer to its previously submitted qualifications.

(2) The written sampling plan must identify the sampler and sampling firm and must list factors that will be controlled to ensure the sampling does not impact the validity of the subsequent analytical testing, including controlling for the representational nature of the sample; and

(3) The written sample collection report must include:

(i) The product code of the food product (if product is being sampled) or the location and a description of the environment (if environment is being sampled);

(ii) The date of the sampling;

(iii) The lot number, size, identity, and quantity of the sample;

(iv) Documentation of sample collection procedures and any sample preparation techniques; and

(v) Documentation of the chain of custody of the sample and of measures taken to ensure the validity of the subsequent analytical testing, including controlling for the representational nature of the sample.

(c) In addition to the documentation required to be submitted with all test results (see § 1.1152(c)), an abridged analytical report must include:

(1) 2017(E) (incorporated by reference, see § 1.1101) sections 7.8.2.1(a) through (p) and 7.8.3.1(a) through (d); and

(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).

(d) The LAAF-accredited laboratory must document the testing information and test results to the extent necessary to account for all information that is required to be included in a full analytical report (see § 1.1152(d)).

(2) Documentation of food testing the LAAF-accredited laboratory conducted under this subpart sufficient to account for all information required by § 1.1152(d), in accordance with § 1.1150(d);