# FDA 483 - Hetero Drugs Ltd. - Unit 1 - May 16, 2025

Source: https://www.keypedia.com/records/483/hetero-drugs-ltd-unit-1/380fe241-c7a9-4330-bbe5-26066c4980b8

> FDA 483 for Hetero Drugs Ltd. - Unit 1 on May 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hetero Drugs Ltd. - Unit 1
- Inspection Date: 2025-05-16
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Hetero Drugs Ltd. - Unit 1, an API manufacturer in Gummadidala, Telangana, India, was cited with two observations during an FDA inspection. The firm failed to conduct adequate risk assessments and testing for the formation of a known carcinogen in drug products and lacked proper cleaning validation procedures to prevent hazardous drug residue cross-contamination on shared equipment. These issues indicate significant concerns regarding product quality and safety.

## Related Documents

- [483 - 2018-03-02](https://www.keypedia.com/records/483/hetero-drugs-ltd-unit-1/f6db977b-5b72-4d7e-80c4-216e53e6c01d)
- [EIR - 2020-02-14](https://www.keypedia.com/records/eir/hetero-drugs-ltd-unit-1/f2d0cfb9-2f77-4c33-b458-bfeb465a8c6b)
- [483 - Unknown Date](https://www.keypedia.com/records/483/hetero-drugs-ltd-unit-1/2f5e8642-953a-44f2-b954-3649b3a9f37d)

## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.keypedia.com/companies/hetero-drugs-ltd-unit-1/4c15935a-9ff7-4f66-b649-3d78aa3e9753

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