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483
•kdc/one Chatsworth, Inc.•February 3, 2020

kdc/one Chatsworth, Inc. – FDA 483, Feb 3, 2020

Record Details

An FDA inspection of Brilliant International, Inc. in Chatsworth, CA, revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations. Observations included inadequate employee training, failure to follow complaint handling procedures, poor equipment maintenance leading to product spills, and incomplete laboratory records for reference standards. These findings indicate a need for comprehensive corrective actions to ensure product quality and safety.

Company
kdc/one Chatsworth, Inc.
Inspection date
February 3, 2020
Product type
drugs
Office
Division of Pharmaceutical Quality Operations IV
Person
  • Taichun Qin (Consumer Safety Officer, Drug Specialist)
View Company Profile

ID · b444c7c0-01a4-40c5-8633-0d248f3fc141

Other documents for kdc/one Chatsworth, Inc.
  • 483 - 2018-05-25May 25, 2018

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