ARJ Infusion Services, Inc.
Form 483 issued May 25, 2017 · Lenexa, Kansas
- Inspection
- May 16 – May 25, 2017
- Investigator
- Robert J. Ham
- Observations
- 3
- Pages
- 2
- FEI number
- 3013452490
In short: On May 25, 2017, FDA issued a Form 483 with 3 observations to ARJ Infusion Services, Inc. in Lenexa, Kansas (FEI 3013452490) after an inspection that ran May 16 – May 25, 2017. The investigator was Robert J. Ham. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Equipment used in the processing, sterile drug products is not of appropriate design to facilitate operations…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Robert J. Ham
32 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
The firmARJ Infusion Services, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ARJ Infusion Services, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected ARJ Infusion Services, Inc.?
Robert J. Ham is named on this Form 483, for the inspection of May 16 – May 25, 2017. Each investigator has a profile showing what they cite most.
When was ARJ Infusion Services, Inc. inspected by FDA?
The inspection ran May 16 – May 25, 2017, and the Form 483 is dated May 25, 2017.
How do I get the full Form 483 for ARJ Infusion Services, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.