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

Source: https://www.keypedia.com/records/483/providence-health-and-services-washington-dba-providence-infusion-hospital-services/cc60e713-87fb-4a67-8d82-1f91cfe179a1

> 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: Center for Drug Evaluation and Research
- Summary: During an FDA inspection from September 8 to October 5, 2020, Providence Health and Services Washington Dba Providence Infusion Hospital Services, an outsourcing facility located at 3333 S 120th Pl Ste 100c, Tukwila, WA 98168-5134, was cited for four observations.

Observation 1 noted deficiencies in environmental monitoring within aseptic processing areas. Specifically, the firm failed to monitor total particle counts in the ISO 5 area during production from March 2 to October 2, 2020. During this period, (b)(4) batches were produced and (b)(4) batches distributed for patient use, including products like HYDROmorphone, Buffered Lidocaine, ceFAZolin, and fentaNYL/Bupivacaine combinations.

Observation 2 stated that drug products purporting to be sterile and pyrogen-free were not laboratory tested for conformance. The firm did not conduct endotoxin testing prior to releasing sterile drug products, such as fentaNYL/Bupivacaine 250mL bags.

Observation 3 indicated that the outsourcing facility failed to submit a report to FDA identifying all drugs compounded during the previous six-month period. Specific fentaNYL/Bupivacaine products were compounded but not included in the report dated (b)(4).

Observation 4 detailed multiple deficiencies in drug product labeling.

## Related Documents

- [483 - 2020-10-05](https://www.keypedia.com/records/483/providence-health-and-services-washington-dba-providence-infusion-hospital-services/bc757b0f-c61a-47e4-baff-9f3837abbba7)
- [483 - 2022-04-13](https://www.keypedia.com/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.keypedia.com/people/nathaniel-b-phillips-sylvain/34a64fcb-7add-4aad-a507-4af7e2b4cf9b)
- [Consumer Safety Officer](https://www.keypedia.com/people/kenneth-o-gee/d61312c0-1422-4487-a5d6-ec6e76d242ee)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c