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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Report of Telephone Conversation - EVARREST, June 7, 2011



Date/Time of Call :June 7, 2011

Randa Melhem, CMC Reviewer/Inspector, OCBQ/DMPQ
Marion Michaelis, Team Lead, OCBQ/DMPQ

Susan Miller, VP QA Omrix
Christie Bielinski, Group Director, Quality and Compliance
J&J Wound Management
Paul Fitton, Cleaning and Shipping Validation Lead
Dieter Bachmann, Quality Site Lead, Jerusalem Plant

Organization: Omrix Biopharmaceuticals Ltd. / Ethicon Inc.
Telephone: ----(b)(4)----
Discussion about the 483 observation regarding (b)(4) acceptance limits of -----(b)(4)----- of equipment.


During the PLI (May 10-19, 2011), Omrix was cited on the FDA form 483 that “the acceptance criterion for --------------------------------------------------------------------------------------(b)(4)-------------------------------------------------------------. Use of this criterion would allow for potential unclean equipment to be utilized in the next production run”. Omrix/Ethicon requested a telecon with FDA to discuss the intent of this section of the observation: allow for potential unclean equipment to be utilized in the next production run.

During the telecon, FDA reiterated that the acceptance criterion is too high, and that if the equipment is clean, the ----(b)(4)---- should meet (b)(4) specifications ---(b)(4)---. FDA added that the (b)(4) specifications should be set based on the cleaning procedure capabilities, and in line with (b)(4) specifications. Omrix/Ethicon clarified that ----(b)(4)---- specification has been set according to the ------(b)(4)---------------------- guideline and is considered to ensure both safety and cleanliness. They added that they will review their historical data, and would adjust the (b)(4) acceptance criterion to align with the capability of the cleaning process to ensure better control.