# FDA 483 - Hetero Labs Ltd. - Unit IX - May 14, 2019

Source: https://www.keypedia.com/records/483/hetero-labs-ltd-unit-ix/7bc98be1-a256-46dd-a3b6-45f39f9de716

> FDA 483 for Hetero Labs Ltd. - Unit IX on May 14, 2019. 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: 2019-05-14
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Hetero Lab Limited Unit IX, an API manufacturer in Nakkapally, India, was cited for significant deficiencies during an FDA inspection. Observations included inadequate investigations into impurity contamination and risk evaluation, unvalidated cleaning processes for non-dedicated equipment, and reprocessing of materials using unvalidated methods without stability data. These issues indicate a lack of robust quality control and process validation.

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## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)
- [FDA Alumnus, Principal at ESCODA Consulting Group, and Scientific Advisory Board Member at AiZen Algo](https://www.keypedia.com/people/concepcion-cruz/831264a6-1a6b-47f1-b0bf-f3091d3b2f1c)

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

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4