# FDA 483 - K.C. Pharmaceuticals, Inc - August 28, 2024

Source: https://www.globalkeysolutions.net/records/483/kc-pharmaceuticals-inc/42bdb612-a9ab-4ece-b326-86e0cd897a7c

> FDA 483 for K.C. Pharmaceuticals, Inc on August 28, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: K.C. Pharmaceuticals, Inc
- Inspection Date: 2024-08-28
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of K.C. Pharmaceuticals, Inc. in Pomona, CA, a manufacturer of sterile drug products, revealed significant deficiencies across multiple quality systems. Observations included failures in quality control unit responsibilities, inadequate stability testing, insufficient aseptic process validation, uncontrolled access to labeling materials, and unreviewed laboratory records. Additionally, the firm's water purification system validation was found to be inadequate, indicating a broad pattern of non-compliance with GMP regulations.

## Related Documents

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

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.globalkeysolutions.net/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [ analyst /Microbiologist ](https://www.globalkeysolutions.net/people/ana-maria-a-plapcianu/5f370fbd-8ff9-4fcf-ad57-380201abc7cd)
- [issuing_officer](https://www.globalkeysolutions.net/people/ngozi-g-offor/d9d0aa28-6bd1-4427-a712-8716c96b1f3d)

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

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