Overview
- 6 public-safe observations are available for this inspection.
- 1 structured CFR citation is represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
30 Jul 2019
FDCA 501(a)(2)(A)
Disinfecting materials, aseptic processing area
Cited by Sena G Dissmeyer
30 Jul 2019
FDCA 501(a)(2)(A)
First pass air blockage, open unit with sterile product
Cited by Sena G Dissmeyer
Inspected site
IIInfuScience, Inc. dba Bioscrip Infusion ServicesChantilly, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 6x |
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 6 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