ECI Pharmaceuticals - Nov. 18, 2016
Issue Date
Nov 18, 2016
Region
Southeast
Category
Drug
$117.00
Contact Name
Abul K. Bhuiyan
Contact Title
VP of Operations & Chief Scientific Officer
Address 1
5311 N.W. 35th Terrace
City
Ft. Lauderdale
State
FL
Zip/Postal Code
33309
Country
United States
Inspection Range
Nov 07, 2016 - Nov 18, 2016
Pages
6
First Observation
The in-process control procedures were deficient in that they did not include an examination of the adequacy of mixing to assure uniformity and homogeneity.
Investigator(s): Ileana Barreto-Pettit and Jennifer Lalama