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

Source: https://www.keypedia.com/records/483/hetero-labs-ltd-unit-ix/a9538a13-016c-40c8-a7df-68910eede01a

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

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## Details

- Record Type: 483
- Company Name: Hetero Labs Ltd. - Unit IX
- Inspection Date: 2025-09-26
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Hetero Labs Limited, Unit-IX, an API manufacturer in Narasapuram Village, India, was cited for significant quality control and data integrity issues during an FDA inspection. The firm was found to be using an unregistered testing laboratory and an undocumented offsite warehouse, leading to a lack of traceability for APIs and intermediates. Additionally, the inspection revealed destroyed GMP documents, falsified training agreements, and uninvestigated Out of Specification results, indicating severe deficiencies in their quality unit and record-keeping practices.

## Related Documents

- [483 - 2019-05-14](https://www.keypedia.com/records/483/hetero-labs-ltd-unit-ix/7ae33c50-5478-4036-847c-57491e2d9696)
- [483 - 2019-05-14](https://www.keypedia.com/records/483/hetero-labs-ltd-unit-ix/7bc98be1-a256-46dd-a3b6-45f39f9de716)
- [483 - 2022-11-08](https://www.keypedia.com/records/483/hetero-labs-ltd-unit-ix/00df0fd4-9f6a-45ea-9d14-e206d2fde28f)
- [483 - 2025-09-26](https://www.keypedia.com/records/483/hetero-labs-ltd-unit-ix/1122e056-7a9c-4b0e-aaa0-2b2217353a70)

## Related Officers

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

Company: https://www.keypedia.com/companies/hetero-labs-ltd-unit-ix/b44e59b6-5413-4ef1-83a3-411f3684bdc3

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8