483
Caplin Steriles LimitedFDA 483 - Caplin Steriles Limited - June 14, 2019
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An FDA inspection of Caplin Steriles Limited in Gummidipoondi, India, revealed significant deficiencies in procedures designed to prevent microbiological contamination of sterile drug products. The firm also lacked adequate training for employees performing 100% visual inspection of injectable drug products, raising concerns about product quality and patient safety.
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ID · 1c674607-505f-4a1c-a8c5-24fc7ca4cced