# FDA 483 - MACSEN DRUGS - September 06, 2024

Source: https://www.globalkeysolutions.net/records/483/macsen-drugs/54265066-d37e-4490-a3b2-a10d774e5828

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

---

## Details

- Record Type: 483
- Company Name: MACSEN DRUGS
- Inspection Date: 2024-09-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: MACSEN DRUGS, an API manufacturer in Udaipur, India, received a Form 483 citing significant deficiencies across its quality, laboratory, and production systems. Key issues include releasing fire-impacted products without retesting, inadequate stability testing after chamber failures, and failures in water system requalification and environmental monitoring. The firm also demonstrated poor data integrity practices, an inadequate preventative maintenance program, and insufficient cleaning validation for production equipment.

## Related Documents

- [483 - 2024-09-06](https://www.globalkeysolutions.net/records/483/macsen-drugs/7aec2348-bffd-437e-b000-eec912c99cb5)

## 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-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8