# FDA 483 - K.C. Pharmaceuticals, Inc - February 13, 2023

Source: https://www.keypedia.com/records/483/kc-pharmaceuticals-inc/7f927619-2f9a-494b-bf17-5943a9949adf

> FDA 483 for K.C. Pharmaceuticals, Inc on February 13, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: K.C. Pharmaceuticals, Inc
- Inspection Date: 2023-02-13
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: K.C. Pharmaceuticals, Inc. in Pomona, CA, was inspected for its sterile drug product manufacturing operations. The inspection revealed significant deficiencies across multiple areas, including inadequate process validation, environmental controls, cleaning procedures, and complaint handling. Additionally, issues were noted with laboratory record review, sterilization process validation, test method specificity, and quality control unit procedures, indicating a broad lack of adherence to current Good Manufacturing Practices.

## 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 - 2024-08-28](https://www.keypedia.com/records/483/kc-pharmaceuticals-inc/42bdb612-a9ab-4ece-b326-86e0cd897a7c)

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [investigator](https://www.keypedia.com/people/amir-alavi/d7179128-eb3f-489e-97cf-e2c5e5539a00)

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