# FDA 483 - National Jewish Health - March 09, 2020

Source: https://www.globalkeysolutions.net/records/483/national-jewish-health/36a21c32-1b91-4c13-9236-c55226e95066

> FDA 483 for National Jewish Health on March 09, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: National Jewish Health
- Inspection Date: 2020-03-09
- Product Type: other
- Office Name: Denver District Office
- Summary: National Jewish Health, a GLP Analytical Laboratory in Denver, was cited with a Form 483 for multiple deficiencies during an inspection. The observations highlight failures in study director oversight, inadequate standard operating procedures for nonclinical laboratory studies, and shortcomings in the quality assurance unit's review of final study reports. Additionally, the facility lacked established SOPs for reagent management within its Complement Laboratory.

## Related Officers

- [Theressa B. Smith](https://www.globalkeysolutions.net/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)
- [issuing_officer](https://www.globalkeysolutions.net/people/ruth-a-williams/f6dd5e30-fe9a-4b18-9703-dc471a55f24f)

Company: https://www.globalkeysolutions.net/companies/national-jewish-health/b54db90a-a6b7-45be-acde-0df4cd723468

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face