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15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.
42 FR 15553, Mar. 22, 1977, unless otherwise noted.
86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022, unless otherwise noted.
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(a) A LAAF-accredited laboratory that FDA has put on probation for one or more methods is permitted to continue to conduct food testing under this subpart; however, a LAAF-accredited laboratory that is on probation for one or more methods is not permitted to submit abridged analytical reports for the major food testing discipline of which the probationary methods are part.
(b) If FDA disqualifies a LAAF-accredited laboratory for all methods within its scope of LAAF-accreditation, the laboratory is immediately ineligible to conduct food testing under this subpart. If FDA disqualifies a LAAF-accredited laboratory for specific methods within the scope of LAAF-accreditation, the laboratory is immediately ineligible to use the methods for which the laboratory has been disqualified to conduct food testing under this subpart.
(c) With respect to food testing conducted by the laboratory prior to its disqualification, FDA may refuse to consider results and associated reports of food testing conducted under this subpart if the basis for the disqualification of the laboratory indicates that the specific food testing conducted by the laboratory may not be reliable.
(d) Within 10 business days of the date of issuance of disqualification, the laboratory must provide the name and email address of the custodian who will maintain and make available to FDA the records required by § 1.1154, and the street address where the records will be located.
(e) Within 10 business days of the date of issuance of a notice of probation or disqualification, the laboratory must notify any owners or consignees for which it is conducting food testing using methods for which it is being placed on probation or disqualified under this subpart, that it is on probation or has been disqualified.