Date: Feb 23, 2018
February 26, 2018 – Keller and Heckman LLP is pleased to announce the introduction of its Audit and Inspection Program (AIP) for Tobacco and Vapor Product Manufacturing Establishments.
The AIP was developed in response to the Food and Drug Administration’s (FDA) inspection authority under the Food, Drug, and Cosmetic Act (FDCA or the Act), as amended by the Tobacco Control Act, which provides that FDA shall inspect each factory, warehouse, establishment, or vehicle in which tobacco products, including deemed tobacco products, are manufactured, processed, packed, or stored. Pursuant to Sections 704 and 905 of the Act, FDA is directed to inspect every establishment at least once every two years.
Audit and Inspection Program
Keller and Heckman’s experienced team of attorneys and scientists will provide a comprehensive, on-site training and facility auditing program designed to help your company adequately prepare for an FDA inspection. As part of the AIP, companies can expect:
Keller and Heckman’s AIP program is designed to provide companies that are involved in any aspect of the tobacco or vapor product supply chain with confidence that their facilities are operating in accordance with FDA requirements. The AIP will consider a broad range of inspection activities, including: recordkeeping, product labeling, product samples, requests for video/audio/photographic recordings, standard operating procedures, cleanliness and sanitation, inventory control, and personnel interviews.
Supplemental Environmental and OSHA Compliance Components
In addition to FDA compliance, the AIP offers companies the option to include supplemental compliance training and auditing focusing on environmental and occupational health and safety regulations and requirements – efficiently leveraging the FDA mock inspection and full facility audit.
Pre-registration for the AIP is available immediately by filling out the form available here:
Tobacco and Vapor Product Manufacturing Establishment Audit and Mock Inspection Program Pre-Registration Form
The completed pre-registration form can be E-mailed to firstname.lastname@example.org, faxed to (202) 434-4646, or mailed to:
Keller and Heckman LLP
Attn: Azim Chowdhury
1001 G Street NW, Suite 500 West
Washington, D.C. 20001
Upon receipt of your pre-registration form, Keller and Heckman will provide your company with a formal written proposal and cost-estimate to conduct on-site training and mock inspection at your facility. Scheduling is generally available on a first-come, first-serve basis.
*The written post-inspection report is covered by any existing attorney-client relationship between Keller and Heckman and the Company, and is generally not subject to discovery. The recommendations set forth in the post-inspection report are for informational purposes only, and do not constitute any warranties or guarantees regarding the outcome of an actual FDA, EPA or OSHA inspection. Keller and Heckman’s attorneys remain available and look forward to the opportunity to assist with any post-inspection activities or questions following completion of the written report.