# FDA 483 - Ceba-Tek, Inc. - February 17, 2023

Source: https://www.globalkeysolutions.net/records/483/ceba-tek-inc/fe0cd318-9d2f-41db-bd15-6a87a2010469

> FDA 483 for Ceba-Tek, Inc. on February 17, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ceba-Tek, Inc.
- Inspection Date: 2023-02-17
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Ceba-Tek, Inc., a dietary supplement contract manufacturer in Melbourne, FL, revealed seven significant observations, many of which were repeated from prior inspections. The firm failed to establish adequate specifications for components and finished products, qualify suppliers, and maintain master manufacturing records. Additionally, issues were noted with equipment controls for blending and general equipment sanitation, including an insect found on a capsule polishing brush.

## Related Documents

- [WARNING_LETTER - 2019-02-05](https://www.globalkeysolutions.net/records/warning_letter/ceba-tek-inc/d597eafd-71aa-4460-a4e4-b468e4880213)

## Related Officers

- [Juan C. Gonzalez Rivera](https://www.globalkeysolutions.net/people/juan-c-gonzalez-rivera/89cede20-6837-417d-b4d8-223eda5b641d)
- [investigator](https://www.globalkeysolutions.net/people/jason-p-aun/20429e2c-7e11-42c8-b612-b0512fe87dac)

Company: https://www.globalkeysolutions.net/companies/ceba-tek-inc/1d0e3131-fa1e-4517-9165-59ba45de45f7

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