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

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.