Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Oct 2020
21 CFR 211.167(a)
Sterility/pyrogen-free testing
Cited by Kenneth O Gee, Nathaniel B Phillips Sylvain
5 Oct 2020
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Kenneth O Gee, Nathaniel B Phillips Sylvain
5 Oct 2020
FDCA 503B(a)(10)
Drug product label, outsourcer facility
Cited by Kenneth O Gee, Nathaniel B Phillips Sylvain
5 Oct 2020
FDCA 503B(b)(2)(A)
Outsourcing facility, compounded drug report follow up
Cited by Kenneth O Gee, Nathaniel B Phillips Sylvain
Inspected site
PHProvidence Health and Services Washington Dba Providence Infusion Hospital ServicesTukwila, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(b)(2)(A) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 4 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere