# FDA 483 - CA-BOTANA INTERNATIONAL - April 04, 2025

Source: https://www.globalkeysolutions.net/records/483/ca-botana-international/7df8886e-7e05-4f7a-9691-554a3cab829b

> FDA 483 for CA-BOTANA INTERNATIONAL on April 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CA-BOTANA INTERNATIONAL
- Inspection Date: 2025-04-04
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: CA BOTANA International, Inc. in San Diego, CA, an OTC drug manufacturer, received a Form 483 with five observations during an inspection from April 2-4, 2025. The inspection revealed significant issues with quality control, equipment qualification, laboratory controls, and component testing, many of which were repeated from a previous inspection. The firm failed to validate manufacturing processes, qualify equipment and water systems, investigate out-of-specification results, qualify contract testing laboratories, and test high-risk components like glycerin for impurities.

## Related Documents

- [483 - 2019-11-12](https://www.globalkeysolutions.net/records/483/ca-botana-international/d0b00837-03ad-40de-9b02-c1e7694814f0)

## Related Officers

- [Cecilia H. Kieu](https://www.globalkeysolutions.net/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)

Company: https://www.globalkeysolutions.net/companies/ca-botana-international/c3bf0bd8-58db-470b-8e1f-3b8c79511764

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