# FDA 483 - MACSEN DRUGS - September 06, 2024

Source: https://www.globalkeysolutions.net/records/483/macsen-drugs/7aec2348-bffd-437e-b000-eec912c99cb5

> FDA 483 for MACSEN DRUGS on September 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MACSEN DRUGS
- Inspection Date: 2024-09-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: MACSEN DRUGS, an API manufacturer in Udaipur, Rajasthan, India, received a Form 483 with eight observations highlighting significant quality system deficiencies. These include failures in ensuring product quality after a fire, inadequate stability testing, improper water system requalification, and poor environmental monitoring. The inspection also revealed serious data integrity issues, insufficient electronic equipment maintenance, a deficient preventative maintenance program, and inadequate cleaning validation for production equipment.

## Related Documents

- [483 - 2024-09-06](https://www.globalkeysolutions.net/records/483/macsen-drugs/54265066-d37e-4490-a3b2-a10d774e5828)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/macsen-drugs/d566779f-f5f3-4d75-8cd2-ca281c31c4c9

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