# FDA 483 - Harman Finochem Limited - March 18, 2024

Source: https://www.keypedia.com/records/483/harman-finochem-limited/21b993cf-a4a3-45d8-bb8e-2c7561d4da21

> FDA 483 for Harman Finochem Limited on March 18, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Harman Finochem Limited
- Inspection Date: 2024-03-18
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Harman Finochem Ltd. in Aurangabad, India, revealed deficiencies in laboratory controls. Specifically, the firm's methods for microbiological analysis of water used in non-sterile active pharmaceutical ingredient production were not scientifically sound, lacking proper validation and justification for testing procedures. This indicates a significant concern regarding the quality assurance of raw materials.

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

Company: https://www.keypedia.com/companies/harman-finochem-limited/7622941a-bad2-45c3-bd91-07d2bb63f905

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