Hetero Labs Limited, Unit-IXSeptember 26, 2025

FDA 483 - Hetero Labs Limited, Unit-IX - September 26, 2025

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The document provided for summarization is incomplete and lacks the actual content of the FDA 483 report. Therefore, a summary cannot be generated. Please provide the full text of the report for analysis, including the company name, inspection dates, and details of any observations, to allow for a comprehensive summary of the main violations/issues, regulatory framework, and required actions.

Company: Hetero Labs Limited, Unit-IX
Inspection Date: September 26, 2025
Product Type: Other
Office: Office of the Commissioner
People: Tamil Arasu (Consumer Safety Officer - Dedicated Foreign Drug Cadre)
Lisa L. Flores (Consumer Safety Officer/ Federal Investigator)
Pratik S. Upadhyay

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ID · aa0047ff-3f44-40fc-a4f6-80be73c5fe1b