Infusion Partners
Form 483 issued September 25, 2018 · Sharpsburg, Pennsylvania
- Inspection
- Sep 25, 2018
- Investigator
- Marcus A. Ray
- Observations
- 2
- Pages
- 1
- FEI number
- 3011127887
In short: On September 25, 2018, FDA issued a Form 483 with 2 observations to Infusion Partners in Sharpsburg, Pennsylvania (FEI 3011127887) after an inspection that ran Sep 25, 2018. The investigator was Marcus A. Ray. Most observations concern production; the most-cited regulation is 21 CFR 211.28 (personnel responsibilities).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.28 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel donned gowning apparel improperly, in a way that may have caused the gowning…
- 02
Disinfecting agents and cleaning pads or wipes used in the ISO 5 area [aseptic processing…
This inspection in context
Marcus A. Ray
14 documents · 2017–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmInfusion Partners history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.28
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Infusion Partners?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.28 (personnel responsibilities). The opening words of each observation are shown on this page.
Who inspected Infusion Partners?
Marcus A. Ray is named on this Form 483, for the inspection of Sep 25, 2018. Each investigator has a profile showing what they cite most.
When was Infusion Partners inspected by FDA?
The inspection ran Sep 25, 2018, and the Form 483 is dated September 25, 2018.
How do I get the full Form 483 for Infusion Partners?
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.