Resources for Private Laboratory Testing

Import alerts inform FDA staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of FDA laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information. If a product is detained without physical examination, importers have the right to provide evidence to FDA in an attempt to overcome the appearance of the violation. Depending on the type of issue covered by the import alert, submitting private laboratory analytical reports may be useful as evidence to overcome the appearance of the violation.

Under the FD&C Act section 801, FDA is authorized to refuse admission of FDA-regulated articles offered for import that appear to violate certain provisions of the FD&C Act, implementing regulations, and/or other laws enforced by FDA.   FDA-regulated articles that appear to violate the FD&C Act are detained and therefore may be subject to refusal of admission by FDA. The importer is informed of the nature of the violation and of the importer’s right to introduce testimony regarding the admissibility of the article (see section 801 [21 U.S.C. § 381] and 21 CFR § 1.94).

This page provides supplementary sampling, method information and sample preparation information to assist private laboratories who are analyzing products being held under DWPE as part an Import Alert to assist private laboratories submit scientifically sounds PLAPS as testimony pursuant to FD&C Act section 801 and 21 CFR 1.94. FDA does not endorse any private laboratory firms, nor requires specific methods to be used for PLAPs. Methods link herein are provided as a courtesy, but private laboratories are not required to use them. The collected sample(s) should be analyzed using appropriate method that have been properly validated.  The PLAP should cite the method(s) used and deviations from official methods should be explained and validated.   Please refer to the current ORA Laboratory Manual, Volume III, Section 7, “Private Laboratory Guidance,” for more comprehensive information about private laboratory package contents and the review process.

Related Import Alerts

Contact FDA

If you have additional questions regarding sample preparation or analytical methodology for products being held under DWPE under an Import Alert, please contact the ORA/Office of Regulatory Science @ [email protected]