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Caribe Holdings (Cayman) Co., Ltd. - March 6, 2019
Issue Date
Mar 06, 2019
Region
Southeast
Category
Drug
$117.00
Contact Name
David Fuster
Contact Title
Plant Manager
Address 1
State Rd., 698 Km 0.8, Bo. Mameyal
City
Dorado
State
PR
Zip/Postal Code
00646
Country
United States
Inspection Range
Feb 21, 2019 - Mar 06, 2019
Pages
11
First Observation
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Investigator(s): Marian E. Ramirez and Jose Velez