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U.S. Department of Health and Human Services

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Progress Report of the 483 Communications Working Group

Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach

Comments on this report or on the activities of this working group should be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with Docket Number 03N-0059.

Electronic Management Comment Form:  Docket 03N-0059 - Pharmaceutical Current Good Manufacturing Practices for the 21st Century: A Risk-Based Approach

The 483 Communications Working Group of the Pharmaceutical GMPs for the 21st Century Initiative was asked to determine the proper mechanism for communicating deficiencies to industry. The group reviewed FDA's process for creating and issuing the Form FDA 483 (483), assessed legal and practical requirements, interviewed internal and external stakeholders, and evaluated perceived misuse of and concerns with the 483. A conclusion was that the purpose and legal intent of the 483 as well as the Agency's process for developing and issuing it may be unclear to some inspected entities and the public. Because such perceived ambiguity may result in inaccurate conclusions about the compliance status of an inspected firm, both by the firm itself and by those seeking information through the FOI process, the group developed additional standard language to be provided to a sponsor along with the form.

We prepared the following language to be provided to the sponsor with the 483 to clarify the purpose and effect of the 483 and alert the recipient about how to object to an observation or how to bring new information to FDA's attention:

"This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above."

This language will also be added to FDA’s website where any 483s and warning letters are posted. The disclaimer will clarify the purpose and scope of the 483. Although the language is addressed to the inspected firm, it will be observed by anyone reviewing the document, thereby setting the document in its proper context. This disclaimer will be implemented promptly for electronically generated forms, and as soon as practicable for printed forms.