# FDA 483 - Madhu Instruments Private Limited - October 21, 2022

Source: https://www.globalkeysolutions.net/records/483/madhu-instruments-private-limited/cd7ae7e7-98cc-4007-8cc7-a89e1c440307

> FDA 483 for Madhu Instruments Private Limited on October 21, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Madhu Instruments Private Limited
- Inspection Date: 2022-10-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Madhu Instruments Private. Limited. in New Delhi, India, a finished sterile drug product manufacturer, revealed significant deficiencies across its quality system. The firm exhibited widespread data integrity issues, inadequate investigations into discrepancies and complaints, and a lack of proper employee training. Additionally, the facility suffered from poor maintenance, insufficient environmental controls, and a failure to validate equipment and processes, all of which compromise the quality and safety of their drug products, particularly (b)(4) mg USP.

## Related Documents

- [WARNING_LETTER - 2022-10-21](https://www.globalkeysolutions.net/records/warning_letter/madhu-instruments-private-limited/87b799d9-699b-4258-a072-f340e035a864)

## Related Officers

- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)
- [Investigator](https://www.globalkeysolutions.net/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.globalkeysolutions.net/companies/madhu-instruments-private-limited/e1dceb04-edc9-4d19-a2ac-7f01101edcb3

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1