Home Infusions Solutions, Inc.
Form 483 issued May 21, 2013 · Horsham, Pennsylvania
- Inspection
- May 3 – May 21, 2013
- Investigator
- Anita R. Michael
- Observations
- 5
- Pages
- 5
- FEI number
- 3009803574
In short: On May 21, 2013, FDA issued a Form 483 with 5 observations to Home Infusions Solutions, Inc. in Horsham, Pennsylvania (FEI 3009803574) after an inspection that ran May 3 – May 21, 2013. The investigator was Anita R. Michael. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacture, processing, packing. or holding of a drug produ<..'t do not have…
- 02
The control .systems necessary to prevent contamination…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Anita R. Michael
18 documents · 2006–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmHome Infusions Solutions, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Home Infusions Solutions, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Home Infusions Solutions, Inc.?
Anita R. Michael is named on this Form 483, for the inspection of May 3 – May 21, 2013. Each investigator has a profile showing what they cite most.
When was Home Infusions Solutions, Inc. inspected by FDA?
The inspection ran May 3 – May 21, 2013, and the Form 483 is dated May 21, 2013.
How do I get the full Form 483 for Home Infusions Solutions, 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.