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

Source: https://www.keypedia.com/records/483/hetero-labs-limited-unit-ix/aa0047ff-3f44-40fc-a4f6-80be73c5fe1b

> FDA 483 for Hetero Labs Limited, Unit-IX on September 26, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hetero Labs Limited, Unit-IX
- Inspection Date: 2025-09-26
- Product Type: other
- Office Name: Office of the Commissioner
- Summary: 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.

## Related Officers

- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)
- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)
- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

Company: https://www.keypedia.com/companies/hetero-labs-limited-unit-ix/8e78f160-d831-49f9-85f2-99523eb02b86

Office: https://www.keypedia.com/offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424