Replies to post #239995 on Biotech Values

[mouton29]

<<I would think either their testing protocol is deficient or the WCB was damaged or contaminated. Revance didn't have a answer to these problems. >>

The answer is a new line, which they initiated in May, no?

From the 483:

c. Quality Investigation Ql-20-003 identified the effectiveness of the WCB as the most likely root cause [for rejected DS GMP lots] and recommended CAPA 21-017 (initiated 5-May 2021, ongoing) to manufacture and qualify new WCB per PROT_QC_271.
d. New WCB is not yet fully qualified.