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

Source: https://www.keypedia.com/records/warning_letter/kc-pharmaceuticals-inc/2884f385-3060-4ad0-9271-1ec653af5a83

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

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## Details

- Record Type: WARNING_LETTER
- Company Name: K.C. Pharmaceuticals Inc.
- Inspection Date: 2023-02-13
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected K.C. Pharmaceuticals Inc. from January 18-27, 2023, and February 10-13, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include:
1.  **Failure to prevent microbiological contamination (21 CFR 211.113(b)):**
    *   **Inadequate Smoke Studies:** Smoke studies for aseptic processing lines were not performed under adequate dynamic manufacturing conditions, with commercial manufacturing starting on one line in 2020 without sufficient studies. A repeat observation, the firm's response was inadequate due to a lack of detailed product impact assessment.
    *   **Incomplete Media Fill Failure Investigations:** Multiple media fill failures since 2020 on both lines had incomplete investigations or were invalidated without adequate scientific justification.

2.  **Inadequate facility design to prevent contamination (21 CFR 211.42(c)(10)):**
    *   **Insufficient Building Management Systems (BMS):** Lack of continuous monitoring and recording of differential pressures; manual recording frequency was inadequate.
    *   **Compromised Aseptic Processing Line:** The ISO 5 aseptic processing line had open ports to the surrounding room, and operators were observed reaching through these ports instead of using installed gloves during aseptic processing and smoke studies.

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## Related Officers

- [Program Division Director](https://www.keypedia.com/people/steven-e-porter/5448db0e-32f0-4e98-8a5f-9f0857373b06)

Company: https://www.keypedia.com/companies/kc-pharmaceuticals-inc/3878963e-e78c-46bd-9c14-3364fb04c44c

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