§ 1.1159. How will FDA oversee LAAF-accredited laboratories?
250 words·~1 min read·
/us/cfr/t21/s§ 1.1159·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)FDA may review the performance of LAAF-accredited laboratories at any time to determine whether the LAAF-accredited laboratory continues to comply with the applicable requirements of this subpart and whether there are deficiencies in the performance of the LAAF-accredited laboratory that, if not corrected, would warrant corrective action, probation, or disqualification under § 1.1161.
(b)In evaluating the performance of a LAAF-accredited laboratory, FDA may review any of the following:
(1)Records the LAAF-accredited laboratory is required to maintain under this subpart;
(2)Records the recognized accreditation body that LAAF-accredited the laboratory is required to maintain under this subpart;
(3)Information obtained by FDA during a review of the LAAF-accredited laboratory conducted pursuant to paragraph
(c)of this section;
(4)Information obtained by FDA during an evaluation of the recognized accreditation body that LAAF-accredits the laboratory;
(5)Analytical reports and test results submitted to FDA; and
(6)Any other information obtained by FDA, including during FDA's inspections or investigations of one or more owners or consignees.
(c)FDA may conduct an onsite review of a LAAF-accredited laboratory at any reasonable time, with or without a recognized accreditation body (or its officers, employees, and other agents) present, to review the performance of a LAAF-accredited laboratory under this subpart. Certain review activities may be conducted remotely if it will not aid in the review to conduct them onsite.
(d)FDA may report any observations and deficiencies identified during its review of LAAF-accredited laboratory performance under this subpart to the recognized accreditation body.