483
Sun Pharmaceutical Industries LimitedSun Pharmaceutical Industries Limited – FDA 483, Jan 20, 2020
Record Details
An FDA inspection of Sun Pharmaceutical Industries Limited, an API manufacturer in Ahmednagar, India, revealed deficiencies in the receiving controls for temperature-sensitive drug ingredients. The firm failed to provide adequate equipment and written procedures for temperature control, specifically by not verifying the temperature of incoming ingredients or data logger records from transporters. This indicates a lack of robust quality control over critical raw material receipt.
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ID · 75890b37-2c1b-4c9d-9eed-2c7e291c25c7
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