OraLabs, Inc
Form 483 issued December 18, 2015 · Parker, Colorado
- Inspection
- Dec 14 – Dec 18, 2015
- Investigators
- Jamie L. Dion· Tenzin Jangchup
- Observations
- 4
- Pages
- 5
- FEI number
- 3001237145
In short: On December 18, 2015, FDA issued a Form 483 with 4 observations to OraLabs, Inc in Parker, Colorado (FEI 3001237145) after an inspection that ran Dec 14 – Dec 18, 2015. The investigators were Jamie L. Dion and Tenzin Jangchup. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Written records of major equipment maintenance are not included…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Written procedures for sampling and testing plans are not followed…
This inspection in context
Jamie L. Dion
11 documents · 2013–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Colorado.
The firmOraLabs, 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 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OraLabs, Inc?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected OraLabs, Inc?
Jamie L. Dion and Tenzin Jangchup are named on this Form 483, for the inspection of Dec 14 – Dec 18, 2015. Each investigator has a profile showing what they cite most.
When was OraLabs, Inc inspected by FDA?
The inspection ran Dec 14 – Dec 18, 2015, and the Form 483 is dated December 18, 2015.
How do I get the full Form 483 for OraLabs, 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.