Coulter HIV test GMP violations cited by FDA in Aug. 6 warning letter.
This article was originally published in The Gray Sheet
COULTER CORP. HIV TEST GMP DEFICIENCIES CITED BY FDA in an Aug. 6 warning letter to the firm for failure to follow standard operating procedures. The warning letter highlights eight good manufacturing practice violations stemming from a 15-day inspection of Coulter's Division of Retrovirology in Hialeah, Florida that took place between April and June.
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