# FDA 483 - CA-BOTANA INTERNATIONAL - November 12, 2019

Source: https://www.globalkeysolutions.net/records/483/ca-botana-international/d0b00837-03ad-40de-9b02-c1e7694814f0

> FDA 483 for CA-BOTANA INTERNATIONAL on November 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CA-BOTANA INTERNATIONAL
- Inspection Date: 2019-11-12
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: CA Botana International, Inc. in San Diego, CA, an OTC drug manufacturer, was cited for significant quality control and manufacturing deficiencies during an FDA inspection. The firm released out-of-specification drug products, used expired active ingredients, and lacked proper validation for equipment and cleaning processes. These issues indicate a systemic failure in ensuring product quality and safety.

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## Related Officers

- [Diane R. Weidley](https://www.globalkeysolutions.net/people/diane-r-weidley/9d67f057-c980-4b7a-abaf-ae534b530662)

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

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