# FDA 483 - Dignity Health - Northridge Hospital Medical Center - November 07, 2017

Source: https://www.keypedia.com/records/483/dignity-health-northridge-hospital-medical-center/fa13c5ae-b2da-468c-9605-b756360375a5

> FDA 483 for Dignity Health - Northridge Hospital Medical Center on November 07, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dignity Health - Northridge Hospital Medical Center
- Inspection Date: 2017-11-07
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: The FDA Form 483 details multiple deficiencies at a facility producing sterile drugs, including potassium phosphate, potassium chloride, Eribulin mesylate, Azacitidine, and Heparin.

Key observations include:
1.  **Facility Design and Air Quality:** The ISO 7 cleanroom, where ISO 5 aseptic processing occurs, uses a plastic strip curtain instead of a permanent door, preventing adequate pressure differential and allowing unclassified air influx. This is a repeat observation from March 2016.
2.  **Cleanroom Contamination Sources:** A sink is present in the ISO 7 cleanroom, used by technicians for handwashing before gowning, where sterile drugs are produced. This is a repeat observation.
3.  **Classification Discrepancies:** Sterile, hazardous drugs are produced in an ISO 5-classified area located within an unclassified room on the 1st-floor satellite pharmacy.
4.  **Structural Integrity:** Unsealed, loose ceiling tiles and visible gaps around recessed sprinkler heads were observed in the ISO 7 cleanroom, impacting the ISO 5 aseptic processing area.
5.  **Personnel Flow and Gowning:** No designated anteroom exists; technicians enter the ISO 7 cleanroom in street clothes to don sterile gowns. This is a repeat observation.
6.  **Cleaning and Disinfection:** Sporicidal agents were not consistently applied to ISO 5 surfaces. Materials were not disinfected before entering

## Related Documents

- [483 - 2016-03-11](https://www.keypedia.com/records/483/dignity-health-northridge-hospital-medical-center/e746c6d8-7958-43ba-9931-bad79ef4183b)
- [WARNING_LETTER - 2016-03-11](https://www.keypedia.com/records/warning_letter/dignity-health-northridge-hospital-medical-center/e4f2999d-6dba-41ac-9fdb-f1ca94be5d86)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)
- [Uttaniti Limchumroon](https://www.keypedia.com/people/uttaniti-limchumroon/ce890cbf-2f5c-498f-917c-0edf8b10d356)
- [Compliance Officer](https://www.keypedia.com/people/andrew-k-haack/d0e236ac-3223-43e0-8378-300de21b19f5)

Company: https://www.keypedia.com/companies/dignity-health-northridge-hospital-medical-center/f2e902a3-9820-4bed-9bd0-682f3ce87385

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