# FDA 483 - Calapro Inc Dba Calatex Inc - August 21, 2019

Source: https://www.globalkeysolutions.net/records/483/calapro-inc-dba-calatex-inc/c32297dc-b1cb-4945-b1ff-94c238415c18

> FDA 483 for Calapro Inc Dba Calatex Inc on August 21, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Calapro Inc Dba Calatex Inc
- Inspection Date: 2019-08-21
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Calapro Inc Dba Calatex Inc, an importer in Santa Ana, CA, was inspected by the FDA from August 20-21, 2019. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding the lack of established procedures for complaint handling, Medical Device Reporting (MDR), and corrective and preventive actions. These findings indicate a fundamental absence of critical operational controls.

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- [483 - 2025-08-27](https://www.globalkeysolutions.net/records/483/calapro-inc-dba-calatex-inc/3737184a-5af3-49ac-84c3-385d4524d03b)

## Related Officers

- [Angelica G Aziz](https://www.globalkeysolutions.net/people/angelica-g-aziz/3aea89c9-72d6-4865-984e-936dd61d2786)

Company: https://www.globalkeysolutions.net/companies/calapro-inc-dba-calatex-inc/b33ebf67-aa2d-413d-af3a-8a9f778f8b8c

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6