# FDA 483 - Providence Health and Services Washington Dba Providence Infusion Hospital Services - October 05, 2020

Source: https://www.globalkeysolutions.net/records/483/providence-health-and-services-washington-dba-providence-infusion-hospital-services/bc757b0f-c61a-47e4-baff-9f3837abbba7

> FDA 483 for Providence Health and Services Washington Dba Providence Infusion Hospital Services on October 05, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Providence Health and Services Washington Dba Providence Infusion Hospital Services
- Inspection Date: 2020-10-05
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Providence Health and Services Washington Dba Providence Infusion Hospital Services in Tukwila, WA, revealed significant deficiencies at their outsourcing facility. Observations included inadequate environmental monitoring in aseptic processing areas, failure to conduct endotoxin testing for sterile drug products, and non-compliance with FDA reporting requirements. Additionally, numerous drug product labels were found to be deficient, lacking critical information such as "This is a compounded drug," dosage form, strength, quantity, and facility contact details.

## Related Documents

- [483 - 2020-10-05](https://www.globalkeysolutions.net/records/483/providence-health-and-services-washington-dba-providence-infusion-hospital-services/cc60e713-87fb-4a67-8d82-1f91cfe179a1)
- [483 - 2022-04-13](https://www.globalkeysolutions.net/records/483/providence-health-and-services-washington-dba-providence-infusion-hospital-services/e41cca10-d1dd-424b-bed5-6ce22aa68706)

## Related Officers

- [Nathaniel B. Phillips-Sylvain](https://www.globalkeysolutions.net/people/nathaniel-b-phillips-sylvain/34a64fcb-7add-4aad-a507-4af7e2b4cf9b)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/kenneth-o-gee/d61312c0-1422-4487-a5d6-ec6e76d242ee)

Company: https://www.globalkeysolutions.net/companies/providence-health-and-services-washington-dba-providence-infusion-hospital-services/2090605c-6b64-42d1-a95a-8f31c909db85

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822