Vann Healthcare Services Inc.
Form 483 issued September 24, 2014 · Glasgow, Kentucky
- Inspection
- Sep 8 – Sep 24, 2014
- Investigator
- Dant Culver
- Observations
- 7
- Pages
- 3
- FEI number
- 1000220363
In short: On September 24, 2014, FDA issued a Form 483 with 7 observations to Vann Healthcare Services Inc. in Glasgow, Kentucky (FEI 1000220363) after an inspection that ran Sep 8 – Sep 24, 2014. The investigator was Dant Culver. 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 5 of 7 observations.
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
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Dant Culver
2 documents · 2013–2014
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Kentucky.
The firmVann Healthcare Services Inc. history
All 3 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 Vann Healthcare Services Inc.?
FDA listed 7 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 Vann Healthcare Services Inc.?
Dant Culver is named on this Form 483, for the inspection of Sep 8 – Sep 24, 2014. Each investigator has a profile showing what they cite most.
When was Vann Healthcare Services Inc. inspected by FDA?
The inspection ran Sep 8 – Sep 24, 2014, and the Form 483 is dated September 24, 2014.
How do I get the full Form 483 for Vann Healthcare Services 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.