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Pharmaceutical cGMPs for the 21st
Century: A Risk-Based Approach
Progress Report of the 483
Communications Working Group
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.
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Date created: February 19, 2003 |
