Unit Dose Solutions, Inc
Form 483 issued July 23, 2015 · Morrisville, North Carolina
- Inspection
- Jul 20 – Jul 23, 2015
- Investigators
- Tamara M. Casselman· Vincent M. Williams
- Observations
- 3
- Pages
- 2
- FEI number
- 3005372033
In short: On July 23, 2015, FDA issued a Form 483 with 3 observations to Unit Dose Solutions, Inc in Morrisville, North Carolina (FEI 3005372033) after an inspection that ran Jul 20 – Jul 23, 2015. The investigators were Tamara M. Casselman and Vincent M. Williams. Most observations concern quality system.
At a glance
3 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that…
- 03
Written procedures are not followed for evaluations done at least(b) (4) and including provisions for a…
This inspection in context
Tamara M. Casselman
1 document · 2015
Cites 211.180(e)(2) (general requirements) more than any other section. Most of their documents are for sites in North Carolina.
The firmUnit Dose Solutions, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Unit Dose Solutions, Inc?
FDA listed 3 observations on this Form 483, mostly about quality system. The opening words of each observation are shown on this page.
Who inspected Unit Dose Solutions, Inc?
Tamara M. Casselman and Vincent M. Williams are named on this Form 483, for the inspection of Jul 20 – Jul 23, 2015. Each investigator has a profile showing what they cite most.
When was Unit Dose Solutions, Inc inspected by FDA?
The inspection ran Jul 20 – Jul 23, 2015, and the Form 483 is dated July 23, 2015.
How do I get the full Form 483 for Unit Dose 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.