# FDA 483 - Hetero Drugs Ltd. - Unit 1 - Unknown Date

Source: https://www.keypedia.com/records/483/hetero-drugs-ltd-unit-1/2f5e8642-953a-44f2-b954-3649b3a9f37d

> FDA 483 for Hetero Drugs Ltd. - Unit 1 on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hetero Drugs Ltd. - Unit 1
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Hetero Drugs Limited, an API drug manufacturer, revealed significant deficiencies in laboratory control testing for Active Pharmaceutical Ingredients. The firm was found to have inhibited integration of HPLC peaks during related substance testing, which could mask impurities, and lacked adequate Standard Operating Procedures for chromatographic practices. These issues indicate a failure to ensure accurate and reliable data for drug products marketed in the United States.

## 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 - 2025-05-16](https://www.keypedia.com/records/483/hetero-drugs-ltd-unit-1/380fe241-c7a9-4330-bbe5-26066c4980b8)

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-l-casner/a0f35f37-4795-4edf-a9f6-a447d64c0fd4)
- [Sneha Patel](https://www.keypedia.com/people/sneha-patel/b7425bea-67ce-4c9b-af5a-51515bdd9f2e)

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