Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd.September 8, 2023

FDA 483 - Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd. - September 08, 2023

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Record Details

An FDA inspection of Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd. revealed two significant observations. The firm failed to adequately follow procedures for handling consumer complaints, specifically regarding the review of retention samples for OTC products distributed in the US. Additionally, the company did not perform adequate stability testing or maintain records to determine appropriate expiration dates for certain drug products released to the US market.

Company: Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd.
Inspection Date: September 8, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Vivin George

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ID · c6c2ced5-9cbc-4340-81e7-42be0f7134e4