483
Alchem International Private LimitedAlchem International Private Limited – FDA 483, Jul 15, 2024
Record Details
Alchem International Limited, an API manufacturer in Neemrana, India, received a Form 483 with two observations. The inspection revealed failures in establishing procedures for verifying USP test methods and in investigating critical deviations. These issues led to the release of potentially impacted product batches without proper assessment, indicating significant deficiencies in quality control and deviation management.
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ID · 6e3fa318-39ce-46ea-8500-2c2d44d7fbcb
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