Chemular - Regulatory Compliance Experts

FDA Inspection Process Announced

by Chemular Staff May 02, 2018

FDA Inspection Process Announced

The FDA has announced their inspection process for Deemed/ENDS tobacco products. They are going to use contractors from State Governments. The FDA will generate the inspectional list from all sources at their disposal (registrations, ingredient listings, web crawls). The commissioner has promised a swift rollout of this process.

The FDA will issue an FDA 482, Notice of Inspection, and not issue FDA 483s. Instead, FDA is providing an Inspectional form that the contract investigator will fill out. They are also mandating use of photography. All commissioned investigators will have background checks, and full FDA training. FDA will highly pursue legal actions because of the inspections, with the commissioned investigators testifying regarding findings. All inspectional data will be transmitted electronically to FDA, within 5 days after closeout of the inspection.

 

FDA states the inspectional process will encompass:

 

Inspection of:

  1. All pertinent equipment, finished and unfinished materials, containers, and labeling therein.
  2. All things therein (including records, files, papers, processes, controls, and facilities) bearing on any violation of the FD&C Act, including whether regulated tobacco products which are adulterated or misbranded within the meaning of the FD&C Act, or which may not be manufactured, introduced into interstate commerce violation of, or sold, or offered for sale by reason of any provision of the FD&C Act (Aug 8,2016 violations), have been or are being manufactured, processed, packed, transported, or held in any such place.

 

In accordance with 21 U.S.C. § 374, inspections shall not encompass inspection or review of any financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to the FD&C Act), and research data (other than data relating to tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to Chapter IX of the FD&C Act (21 U.S.C. § 387 et seq.)).

If an inspection cannot be completed, the Contractor must notify FDA within five (5) business days of initiating the inspection. Notification of an incomplete inspection must be submitted electronically via email to the FDA and must include an explanation of the reason(s) why the inspection could not be completed. c.

 Evidence Storage

The Contractor will ensure proper collection, handling, sealing, documentation, storage, and submission of evidence pursuant to FDA protocol to ensure that evidence is maintained in a manner that shall allow FDA to use the evidence to support an enforcement action. The Contractor shall store evidence for the duration of the contract and shall perform a single transfer of all evidence to FDA or an FDA contractor prior to the end of the contract. The contractor must be capable of being promptly furnished to FDA upon request.

The State Authority must submit completed inspectional form, signed Form FDA 482, and all photographs of evidence to FDA within five (5) business days of initiating the inspection. The Contractor shall submit the completed inspectional form and the signed Form FDA 482 to the FDA within five (5) business days of initiating the inspection.


Chemular Staff
Chemular Staff

Author


Leave a comment