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

Source: https://www.keypedia.com/records/483/hetero-labs-ltd-unit-ix/7ae33c50-5478-4036-847c-57491e2d9696

> 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: Office of Biological Products Operations - Division I
- Summary: Hetero Lab Limited Unit IX, an API manufacturer in Nakkapally, India, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm was cited for inadequate investigations into impurity contamination, poorly established and validated cleaning processes for non-dedicated equipment, and reprocessing of materials using unvalidated manufacturing processes. These issues highlight 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/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1