Medi-Fare Drug & Home Health Center, Inc.
Form 483 issued January 18, 2013 · Blacksburg, South Carolina
- Inspection
- Dec 10, 2012 – Jan 18, 2013
- Investigator
- G. H. Smith
- Observations
- 12
- Pages
- 5
- FEI number
- 3009925820
In short: On January 18, 2013, FDA issued a Form 483 with 12 observations to Medi-Fare Drug & Home Health Center, Inc. in Blacksburg, South Carolina (FEI 3009925820) after an inspection that ran Dec 10, 2012 – Jan 18, 2013. The investigator was G. H. Smith. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 9 of 12 observations.
Most cited: 21 CFR 211.113 (4×) · 211.188 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no assurance that containers, closures, and drug products are…
- 02
Sterility assurance parameters were not met due to your failure to adequately evaluate your define appropriate…
- 03
Observation 3: scanned text, readable in the full document.
- 04
ons have not been rendered free from viable microbes thr~e…
This inspection in context
G. H. Smith
1 document · 2013
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in South Carolina.
The firmMedi-Fare Drug & Home Health Center, Inc. history
All 6 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 Medi-Fare Drug & Home Health Center, Inc.?
FDA listed 12 observations on this Form 483, mostly about production, laboratory controls and quality system. 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 Medi-Fare Drug & Home Health Center, Inc.?
G. H. Smith is named on this Form 483, for the inspection of Dec 10, 2012 – Jan 18, 2013. Each investigator has a profile showing what they cite most.
When was Medi-Fare Drug & Home Health Center, Inc. inspected by FDA?
The inspection ran Dec 10, 2012 – Jan 18, 2013, and the Form 483 is dated January 18, 2013.
How do I get the full Form 483 for Medi-Fare Drug & Home Health Center, 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.