Science & Research
Volume III - 7.1 Objective
Section 7 – Private Laboratory Guidance
|EFFECTIVE DATE: 10/01/2003||REVISED: 01/30/13|
The objective of this section is to establish a uniform, systematic, and effective approach to ensuring that private laboratories performing analyses on FDA-regulated imported commodities submit scientifically sound data. Although FDA has no legislative authority to directly regulate these laboratories, this guidance is provided to ensure the scientific credibility of data submitted to the agency.
Importers are responsible for ensuring that the articles they import comply with all provisions of the Federal Food, Drug and Cosmetic Act. In some instances, products may be detained as soon as they are offered for entry into the United States. This procedure, detention without physical examination (DWPE), is based on past history or other information indicating that the product may be out of compliance with federal laws and regulations. Products or shippers that have met the criteria for DWPE are identified on Import Alerts, which disseminate information to FDA personnel about problems and violative trends. (www.fda.gov/ora/fiars/ora_import_alerts.html )
The owner or consignee of the detained entry has the option of hiring a private laboratory to test the commodity. If the analysis provides evidence that the entry is in compliance with federal laws and regulations, it may be released. In cases where the product has been shown to be out of compliance, the importer may apply for authorization to recondition it. The firm may then contract the services of a private laboratory to assess the reconditioning.
FDA has the obligation of evaluating the analytical data submitted by private laboratories to determine whether import entries comply with the Act and can be released for sale. FDA is to be assured that the scientific data presented is technically valid, has been obtained using sound methods of sampling and analysis, and has recognized quality assurance measures applied.
While this guidance is written in reference to private laboratories, it is really the importer that is ultimately responsible for the entry's compliance with applicable laws and regulations. If a private laboratory does not provide acceptable evidence and documentation to support the credibility of its analysis, the importer bears the responsibility and consequences of the inadequacy.
Although FDA has legal authority over regulated imported products, it does not have such direct authority over the private laboratories. (Note: This applies to private laboratories that analyze imported products. Laboratories that test domestic products may be subject to different regulations. For example, private laboratories used by pharmaceutical firms are to register as manufacturers with the agency and are subject to GMPs. Such laboratories are not addressed in this guidance.) The agency can make decisions on a lot-by-lot basis regarding the entries submitted for importation. The acceptability of the work performed by the private laboratory is an important element in this decision.
It should be noted that because circumstances vary among district offices and laboratories, there is no single set of procedures that can be prescribed for the entire field. For example, districts that are physically near their servicing laboratory can more easily call on them to perform such services as on-site assessment visits than districts that are not. For this reason, this is a guidance document that recommends suggested procedures. Districts and field laboratories may adapt them to their needs.