Curia Global, Inc.January 15, 2019

FDA 483 - Curia Global, Inc. - January 15, 2019

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Record Details

Albany Molecular Research Inc. in Albany, NY, a manufacturer and controlled testing lab, received a Form 483 with four observations. The inspection revealed deficiencies primarily related to inadequate cleaning procedures, failures in following quality control unit responsibilities, and issues with inventory/warehouse systems and batch production records. These observations indicate a lack of adherence to established procedures and potential risks to product quality and traceability.

Company: Curia Global, Inc.
Inspection Date: January 15, 2019
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East I
Person: Rajiv R. Srivastava (Consumer Safety Officer)

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ID · 5cfbda0c-9556-45f8-8815-66bc57da39dd