Clarcon Biological Chemistry Laboratory
Form 483 issued May 4, 2009 · Roy, Utah
- Inspection
- Apr 28 – May 4, 2009
- Investigator
- Matthew R. Dionne
- Observations
- 18
- Pages
- 5
- FEI number
- 3007026789
In short: On May 4, 2009, FDA issued a Form 483 with 18 observations to Clarcon Biological Chemistry Laboratory in Roy, Utah (FEI 3007026789) after an inspection that ran Apr 28 – May 4, 2009. The investigator was Matthew R. Dionne. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
The master production and control records for each batch size of drug product are not prepared…
- 04
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Matthew R. Dionne
2 documents · 2009–2013
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Colorado.
The firmClarcon Biological Chemistry Laboratory history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Clarcon Biological Chemistry Laboratory?
FDA listed 18 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Clarcon Biological Chemistry Laboratory?
Matthew R. Dionne is named on this Form 483, for the inspection of Apr 28 – May 4, 2009. Each investigator has a profile showing what they cite most.
When was Clarcon Biological Chemistry Laboratory inspected by FDA?
The inspection ran Apr 28 – May 4, 2009, and the Form 483 is dated May 4, 2009.
How do I get the full Form 483 for Clarcon Biological Chemistry Laboratory?
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.