# FDA 483 - Calapro Inc Dba Calatex Inc - August 27, 2025

Source: https://www.globalkeysolutions.net/records/483/calapro-inc-dba-calatex-inc/3737184a-5af3-49ac-84c3-385d4524d03b

> FDA 483 for Calapro Inc Dba Calatex Inc on August 27, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Calapro Inc Dba Calatex Inc
- Inspection Date: 2025-08-27
- Product Type: other
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Calatex Inc., an initial importer of Class II condoms in Santa Ana, CA, revealed two significant issues. The firm failed to establish adequate procedures for purchasing controls and did not properly implement its corrective and preventive action (CAPA) procedures, including verifying the effectiveness of past CAPAs. This CAPA deficiency was a repeat observation from a previous inspection.

## Related Documents

- [483 - 2019-08-21](https://www.globalkeysolutions.net/records/483/calapro-inc-dba-calatex-inc/c32297dc-b1cb-4945-b1ff-94c238415c18)

## Related Officers

- [Kevin N. Tran](https://www.globalkeysolutions.net/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

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

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b