FDA 483 - Edwards Lifesciences, LLC - April 11, 2014

From March 3 to April 11, 2014, the FDA inspected Edwards Lifesciences, LLC, a medical device manufacturer located at 12050 Lone Peak Pkwy, Draper, UT. The inspection revealed deficiencies in process validation.

Observation 1 details that processes whose results cannot be fully verified by subsequent inspection and test have not been adequately validated. Specifically: A. The firm's process validation control of (b)(4) processing equipment in the Cardiac System's production room is inadequate, with 89 processes requiring complete validation remaining unvalidated. B. Validation of the (b)(4) (Protocol and Report No. 30428, Add. 1, dated 4/26/2012) was inadequate because: 1. Lot sizes of (b)(4) or (b)(4) units were not representative of routine production rates and did not capture manufacturing variability across shifts/days. 2. The protocol indicated acceptance criteria based on a sample size of (b)(4), but two tests were accepted with reduced sample sizes, and the firm's procedure (GSOP7.4.001, Rev. C) did not justify omitting failed results or unfit units. 3. Three additional routine processing equipment pieces ((b)(4)) were set up without performance qualification data. C. Validation of the (b)(4)