# FDA 483 - Neocis, Inc. - August 11, 2022

Source: https://www.globalkeysolutions.net/records/483/neocis-inc/10976f80-d0b3-4e9c-a2db-4b95f49185b9

> FDA 483 for Neocis, Inc. on August 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neocis, Inc.
- Inspection Date: 2022-08-11
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Neocis, Inc. in Miami, FL, a medical device manufacturer, received three observations during an FDA inspection. The firm was cited for inadequate procedures for corrective and preventive actions, deficiencies in calibration procedures, and a lack of documented personnel training. These findings indicate significant gaps in the firm's quality system documentation and implementation.

## Related Documents

- [483 - 2019-12-11](https://www.globalkeysolutions.net/records/483/neocis-inc/85490023-864c-40a8-8fa0-ffe899982e32)

## Related Officers

- [Nydia E. Colon](https://www.globalkeysolutions.net/people/nydia-e-colon/c5137ded-6ae7-4855-b5b3-113bd851e1c3)

Company: https://www.globalkeysolutions.net/companies/neocis-inc/e347cebf-7548-46b4-88ba-7a997fa684d3

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6