Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2017-11-15.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Nov 2017 – 15 Nov 2017 | Human Drugs | Clean | |
| 15 Sep 2015 – 27 Oct 2015 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Procedures for sterile drug products
Cited by June P Page, Marvin D Jones, Debra A Taylor, Lisa T Michel, Gary C Pecic
Sterility/pyrogen-free testing
Cited by June P Page, Marvin D Jones, Debra A Taylor, Lisa T Michel, Gary C Pecic
Aseptic Processing Area
Cited by June P Page, Marvin D Jones, Debra A Taylor, Lisa T Michel, Gary C Pecic
Environmental Monitoring System
Cited by June P Page, Marvin D Jones, Debra A Taylor, Lisa T Michel, Gary C Pecic
Cleaning System
Cited by June P Page, Marvin D Jones, Debra A Taylor, Lisa T Michel, Gary C Pecic
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Advanced Infusion Solutions Acquisition, LLC's 1 Form 483
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat