Vann Healthcare Services Inc.
Form 483 issued September 30, 2015 · Glasgow, Kentucky
- Inspection
- Sep 15 – Sep 30, 2015
- Investigator
- Michael P. Sheehan
- Observations
- 4
- Pages
- 2
- FEI number
- 1000220363
In short: On September 30, 2015, FDA issued a Form 483 with 4 observations to Vann Healthcare Services Inc. in Glasgow, Kentucky (FEI 1000220363) after an inspection that ran Sep 15 – Sep 30, 2015. The investigator was Michael P. Sheehan. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The control systems necessary to prevent contamination…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Rejected components are not controlled under a quarantine system designed to prevent their use in manufacturing…
- 04
Batch production and control records do not include the specific identification of each batch of component…
This inspection in context
Michael P. Sheehan
6 documents · 2011–2018
Cites 211.113 (control of microbiological contamination) 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 4 observations on this Form 483, mostly about production, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Vann Healthcare Services Inc.?
Michael P. Sheehan is named on this Form 483, for the inspection of Sep 15 – Sep 30, 2015. Each investigator has a profile showing what they cite most.
When was Vann Healthcare Services Inc. inspected by FDA?
The inspection ran Sep 15 – Sep 30, 2015, and the Form 483 is dated September 30, 2015.
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.