# FDA 483 - Novugen Pharma Sdn Bhd - September 07, 2022

Source: https://www.globalkeysolutions.net/records/483/novugen-pharma-sdn-bhd/eaa79122-03c0-476f-923e-6036f13b9273

> FDA 483 for Novugen Pharma Sdn Bhd on September 07, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novugen Pharma Sdn Bhd
- Inspection Date: 2022-09-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Novugen Pharma Sdn Bhd, an oral solid dosage drug manufacturer in Bandar Baru Enstek, Malaysia, revealed significant deficiencies. Observations included inadequate procedures for cleaning validation and protection of clean equipment from contamination, lack of proper identification for major production equipment, and failures in documenting deviation report occurrence dates. These issues indicate a need for improved quality control and adherence to manufacturing standards.

## Related Officers

- [Santos E. Camara](https://www.globalkeysolutions.net/people/santos-e-camara/18cea942-f6f9-4dec-9ce9-1c01c39009ce)

Company: https://www.globalkeysolutions.net/companies/novugen-pharma-sdn-bhd/fc9e6513-920b-4d9b-a395-3599ca7f16e7

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