Medi-Home Infusion Pharmacy
Form 483 issued September 17, 2014 · Irmo, South Carolina
- Inspection
- Sep 8 – Sep 17, 2014
- Investigator
- John J. McKee
- Observations
- 8
- Pages
- 3
- FEI number
- 3010951596
In short: On September 17, 2014, FDA issued a Form 483 with 8 observations to Medi-Home Infusion Pharmacy in Irmo, South Carolina (FEI 3010951596) after an inspection that ran Sep 8 – Sep 17, 2014. The investigator was John J. McKee. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
5 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Buildings used in the processing of a drug product are not maintained in a…
- 04
Observation 4: scanned text, readable in the full document.
- 06
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
This inspection in context
John J. McKee
1 document · 2014
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in South Carolina.
The firmMedi-Home Infusion Pharmacy 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medi-Home Infusion Pharmacy?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment. 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 Medi-Home Infusion Pharmacy?
John J. McKee is named on this Form 483, for the inspection of Sep 8 – Sep 17, 2014. Each investigator has a profile showing what they cite most.
When was Medi-Home Infusion Pharmacy inspected by FDA?
The inspection ran Sep 8 – Sep 17, 2014, and the Form 483 is dated September 17, 2014.
How do I get the full Form 483 for Medi-Home Infusion Pharmacy?
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.