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Investigator/Consumer Safety Officer Imports

The Office of Regulatory Affairs (ORA) is at the forefront of building a public health safety net for today’s complex, global regulatory environment. ORA professionals work in a range of program areas and locations, with 227 offices and 12 laboratories throughout the United States. As the lead office for all FDA field activities, ORA serves as the agency’s direct connection with regulated industry through a) inspections of firms and plants producing FDA-regulated products, b) investigations of consumer complaints, emergencies and criminal activity, c) enforcement of FDA regulations, d) sample collection and analysis, and e) review of imported products.

The Office of Import Operations (OIO) provides advice and counsel to the Associate Commissioner for Regulatory Affairs (ACRA) and other Agency senior leaders on import program operations and activities, and compliance matters. OIO coordinates Agency import activities with U.S. Customs and Border Protection (CBP), including the development and institution of joint regulations, procedures, policies, and operations. Coordinates activities with other Federal agencies and foreign governments through interagency agreements, memoranda of understanding, and informal working relationships.

The Investigator (Imports) has demonstrated and is recognized for a high level of competence in the full range of establishments regulated within the OIO program such as: inspections and investigation of domestic imports and foreign facilities; investigations supporting admissibility decisions for all FDA-regulated commodities imported into the U.S. including hands-on product reviews/sampling and assessment of compliance factors. These types of inspections and investigations will account for a level greater than 90% of the Investigator’s inspectional/investigative work.

Assignments involve a combination of scientific and regulatory responsibilities which usually call for several atypical inspectional or intensive investigative approaches to be applied to a wide variety of regulatory functions or scientific evaluations; and include sample collections, product examinations, establishment inspections, unusual or novel special investigations and conducting objective surveys and emergency activities within the assigned area of responsibility. The Investigator will also perform international inspections.

Inspections and Investigations:
• Independently plans and conducts regulatory inspections and in-depth investigations of various imported products to include sample collections, field examinations, label examinations, filer evaluations, and emergency activities.
• Independently plans and conducts regulatory establishment inspections of importers to ensure compliance with statutory and regulatory requirements such as Foreign Supplier Verification Programs inspections and Seafood HACCP Importer Verification inspections.
• Assignments are frequently complicated by a variety of diverse imported products, ingredients, and additives; highly specialized and sophisticated medical products; complex labeling; record documentation; or uncooperative management.
• Incumbent conducts inspections and investigations to follow up with non-compliant industry establishments on previously noted violations. In situations where compliance is not offered, it is enforced through the detention and refusal process, responding to emergency import situations, warning letters, increased screening, agency meetings and legal court actions.
• The investigator may perform import entry review requiring decisions to release or detain FDA regulated commodities based on document review, product examination and/or sampling following established guidance. The entry reviewer may also issue routine assignments to inspectors and investigators for field examination and sampling.
• Performs routine audits of entry filers (those firms submitting information when presenting FDA regulated products for entry into the U.S.) to assure proper data submission to FDA.
• Performs other duties as assigned.
Analysis and Reporting:
• Incumbent performs analyses and evaluation on import history and data samples and documented information gathered during inspections and investigations to ensure that documentation and practices follow Federal laws, rules, and regulations.
• Documents and organizes required evidence, data, and other information to support violations noted during inspections, investigations, sample collections, field and label examinations, or entry filer audits.
• Developmental assignments include assisting higher level employees in meetings and conference calls with importers, entry filers, consignees, and partner government agencies; assisting in team reviews by gathering scientific and technical comments from team members, assisting with the preparation of letters and correspondence relevant to the review; and contributing to status reports for submissions and investigations under review.
• Incumbent interacts with and advises various levels of officials representing the establishments subject to regulatory review. The incumbent initiates contact with industry officials to obtain basic incomplete or missing information on regulatory and scientific documents and to discuss the status of investigations. Prepares final reports, affidavits, and other written documentation that support investigative findings and recommendations.
• Testifies as an expert witness in administrative hearings and judicial proceedings.
Supervisory Responsibilities: This is a nonsupervisory role.