# FDA 483 - Veterans Affairs Long Beach Health Care System - July 02, 2019

Source: https://www.globalkeysolutions.net/records/483/veterans-affairs-long-beach-health-care-system/691ed8ec-45ea-45e8-b2bc-df3ff11b810b

> FDA 483 for Veterans Affairs Long Beach Health Care System on July 02, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Veterans Affairs Long Beach Health Care System
- Inspection Date: 2019-07-02
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected VA Long Beach Healthcare System's Blood Bank (Transfusion Service) and found significant deficiencies in their quality system. Observations included failures to follow written SOPs for blood component handling and record-keeping, inadequate personnel training for critical tasks, and a lack of established and documented equipment maintenance and calibration procedures for essential storage units. These issues indicate a systemic breakdown in quality control and compliance.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/yvonne-c-wilkes/44e7b094-d09a-48f0-a0ee-f1a6506f935a)

Company: https://www.globalkeysolutions.net/companies/veterans-affairs-long-beach-health-care-system/628614d5-9c35-4952-afc5-5ec8525f1b46

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