# FDA 483 - K.C. Pharmaceuticals, Inc - February 13, 2026

Source: https://www.keypedia.com/records/483/kc-pharmaceuticals-inc/7fb72f69-e3dd-4e53-8a38-ed4c7c7b520f

> FDA 483 for K.C. Pharmaceuticals, Inc on February 13, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: K.C. Pharmaceuticals, Inc
- Inspection Date: 2026-02-13
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA Form 483 was issued to K.C. Pharmaceuticals, Inc. following an inspection that revealed significant deficiencies across multiple areas of their manufacturing operations. The observations highlight critical issues with aseptic processing validation, quality control unit responsibilities, data integrity, batch record completeness, and contamination prevention, indicating a broad lack of adherence to good manufacturing practices.

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## Related Officers

- [Crystal Monroy](https://www.keypedia.com/people/crystal-monroy/b0414886-fb71-4f35-a453-0ad2baf13bfc)
- [Luis F. Torres](https://www.keypedia.com/people/luis-f-torres/0b42aa90-0fa3-407d-bc65-75e270c4dec1)
- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Rowena S. Nguyen](https://www.keypedia.com/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)
- [Investigator](https://www.keypedia.com/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)

Company: https://www.keypedia.com/companies/kc-pharmaceuticals-inc/c82c2f64-5944-429b-a3a9-2f7a567e47d3

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