FDA 483 - Steril-Gene Life Sciences Private Ltd - August 12, 2026
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An FDA inspection of Steril-Gene Life Sciences Private Ltd in Puducherry, India, revealed significant deficiencies across multiple areas of drug manufacturing. The firm failed to maintain aseptic conditions, validate processes, ensure data integrity, and conduct thorough investigations into out-of-specification results and customer complaints. These issues indicate a systemic lack of control over critical manufacturing and quality control operations for products intended for the US market.
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