# FDA 483 - Phoenix Innovative Healthcare Manufacturers Private Limited - September 27, 2024

Source: https://www.keypedia.com/records/483/phoenix-innovative-healthcare-manufacturers-private-limited/56d07290-83a1-465f-83a2-1b8bde6546f7

> FDA 483 for Phoenix Innovative Healthcare Manufacturers Private Limited on September 27, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Phoenix Innovative Healthcare Manufacturers Private Limited
- Inspection Date: 2024-09-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Phoenix Innovative Healthcare Manufacturers Private Limited, a drug manufacturer in Navi Mumbai, India, was inspected and received a Form 483 with six observations. The inspection revealed significant deficiencies in laboratory controls, quality unit investigations, sample retention, production record-keeping, yield reconciliation, and equipment suitability. These issues indicate a lack of robust quality systems and control over manufacturing processes.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)

Company: https://www.keypedia.com/companies/phoenix-innovative-healthcare-manufacturers-private-limited/e8178194-701c-4e86-8bb8-0080fe10cf3f

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8