Infusion Partners
Form 483 issued December 5, 2014 · Sharpsburg, Pennsylvania
- Inspection
- Dec 1 – Dec 5, 2014
- Investigators
- Dorcas A. Taylor· Thomas E. Friel
- Observations
- 5
- Pages
- 4
- FEI number
- 3011127887
In short: On December 5, 2014, FDA issued a Form 483 with 5 observations to Infusion Partners in Sharpsburg, Pennsylvania (FEI 3011127887) after an inspection that ran Dec 1 – Dec 5, 2014. The investigators were Dorcas A. Taylor and Thomas E. Friel. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Dorcas A. Taylor
3 documents · 2014–2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Infusion Partners?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Infusion Partners?
Dorcas A. Taylor and Thomas E. Friel are named on this Form 483, for the inspection of Dec 1 – Dec 5, 2014. Each investigator has a profile showing what they cite most.
When was Infusion Partners inspected by FDA?
The inspection ran Dec 1 – Dec 5, 2014, and the Form 483 is dated December 5, 2014.
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.