Neville Peterson LLP (NPLLP) assists drug, device, and food importers with issues under the Food Drug and Cosmetics Act of the United States. 

Current Good Manufacturing Practices (GMPs) – Food and Drug

Under the Current Good Manufacturing Practices, codified at Parts 211 and 117 of the Title 21 of the Code of Federal Regulations, the Food and Drug Administration (FDA) has the authority to audit or investigate the production practices of various drug and food facilities. The CGMPs provide for systems to assure the proper design, monitoring, and control of manufacturing processes and facilities.  NPLLP may assist with the establishment and design of the proper procedures to comply with the CGMPs, provide the necessary internal review of current practices, and assist in any audit conducted by FDA.

 

Drug and Device Registrations

Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Likewise, owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA.  NPLLP assists with these registrations and ensures that the proper facilities, drug products, and devices are properly registered and listed.

 

Foreign Supplier Verifications

Under the Foreign Supplier Verification Program, importers covered by the rule must have in place a program to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated or misbranded with respect to allergen or other required labeling. An importer is the U.S. owner or consignee of a food offered for import into the United States, or the designated agent of the foreign owner. NPLLP may assist in establishing and designing the elements necessary to assess risks of importation of the food product and how those risks may be evaluated, covered, and corrected under the designed program.

 

FDA Refusals at Ports

NPLLP represents clients before the FDA in matters related to FDA holds, delays, or refusals by assisting in the necessary relabeling of misbranded packaging, working with assigned laboratories to obtain reports on any alleged types of infestation or adulteration, and facilitating any necessary destruction of adulterous products and clearing the shipment for entry.