Allchem Lifescience Private LimitedMay 17, 2024

FDA 483 - Allchem Lifescience Private Limited - May 17, 2024

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Record Details

An FDA inspection of Allchem Lifescience Private Limited, a nonsterile intermediate manufacturer in Vadodara, Gujarat, India, revealed significant deficiencies in quality control. Observations included a lack of a written stability testing program for intermediates, inadequate microbial testing procedures for water and finished products, and failure to follow written sanitation procedures regarding pest control.

Company: Allchem Lifescience Private Limited
Inspection Date: May 17, 2024
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Ankur C. Patel

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ID · f368b8bc-f1dc-4103-935d-b23dd20bb102