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

Source: https://www.keypedia.com/records/483/kc-pharmaceuticals-inc/0b7661f0-1d3c-41ee-b5fe-056d37f8a2a6

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

---

## Details

- Record Type: 483
- Company Name: K.C. Pharmaceuticals, Inc
- Inspection Date: 2026-02-13
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: K.C. Pharmaceuticals, Inc. received a Form 483 citing significant deficiencies across its sterile drug product manufacturing operations. Key issues include inadequate aseptic process validation, failed media fills, deficient environmental monitoring, and a lack of robust quality control oversight. The firm also failed to adequately investigate quality events, manage complaints, and ensure the suitability of its water system and testing methods.

## Related Documents

- [483 - 2009-12-30](https://www.keypedia.com/records/483/kc-pharmaceuticals-inc/cf0f74a9-6c8b-4e64-a901-284bbf398402)
- [483 - 2017-11-16](https://www.keypedia.com/records/483/kc-pharmaceuticals-inc/13310105-63c4-44ce-8bd9-876aae4d9f4f)
- [483 - 2020-01-30](https://www.keypedia.com/records/483/kc-pharmaceuticals-inc/62f4d6c3-b675-4e9c-b5a4-08a1a7831a2a)
- [483 - 2020-01-22](https://www.keypedia.com/records/483/kc-pharmaceuticals-inc/950b990d-655f-4672-9906-291af22ed212)
- [483 - 2023-02-13](https://www.keypedia.com/records/483/kc-pharmaceuticals-inc/7f927619-2f9a-494b-bf17-5943a9949adf)

## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Pearl C. Ozuruigbo](https://www.keypedia.com/people/pearl-c-ozuruigbo/28ec383e-a602-4764-8d14-20b1049f93d7)
- [Nathan E. Hellman](https://www.keypedia.com/people/nathan-e-hellman/88dc6c17-72bf-4c2c-a952-a4ebcd742142)
- [Investigator](https://www.keypedia.com/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)
- [Luis P. Torres](https://www.keypedia.com/people/luis-p-torres/995f71e1-b7b8-4c30-9d53-2127b01f8d47)

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

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