# FDA 483 - Century Pharmaceuticals, Inc. - October 25, 2022

Source: https://www.globalkeysolutions.net/records/483/century-pharmaceuticals-inc/caa085cb-644f-4faf-a40d-7b52d1d2588c

> FDA 483 for Century Pharmaceuticals, Inc. on October 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Century Pharmaceuticals, Inc.
- Inspection Date: 2022-10-25
- Product Type: device
- Office Name: Chicago District Office
- Summary: Century Pharmaceuticals, Inc. in Indianapolis, IN, was cited for multiple quality system deficiencies during an FDA inspection. The observations primarily focused on inadequate procedures for risk analysis, design change, design validation, and process validation for their medical devices. Additionally, issues were noted with corrective and preventive actions, complaint handling, and the maintenance of device master records, indicating a need for comprehensive improvements in the firm's quality management system.

## Related Documents

- [WARNING_LETTER - 2024-11-26](https://www.globalkeysolutions.net/records/warning_letter/century-pharmaceuticals-inc/c4cbf7ef-053c-4101-8072-b205fd3f8420)

## Related Officers

- [Sara M. Onyango](https://www.globalkeysolutions.net/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.globalkeysolutions.net/companies/century-pharmaceuticals-inc/d3898136-aa03-4edc-b005-44709b7f4c67

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669