Optikem International, Inc.
Form 483 issued July 11, 2022 · Denver, Colorado
- Inspection
- Jul 6 – Jul 11, 2022
- Investigator
- Matthew M. Vernon
- Observations
- 2
- Pages
- 4
- FEI number
- 1720129
In short: On July 11, 2022, FDA issued a Form 483 with 2 observations to Optikem International, Inc. in Denver, Colorado (FEI 1720129) after an inspection that ran Jul 6 – Jul 11, 2022. The investigator was Matthew M. Vernon. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.72 (inspection, measuring, and test equipment).
At a glance
2 of 2 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.72(a) (1×) · 820.120(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensure equipment is routinely calibrated have…
- 02
Labeling was not sufficiently examined by a designated individual for accuracy including unique device identifier (UDI)…
This inspection in context
Matthew M. Vernon
6 documents · 2020–2026
Cites 820.20(b)(3) (management responsibility) more than any other section. Most of their documents are for sites in Colorado.
The firmOptikem International, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.72(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Optikem International, Inc.?
FDA listed 2 observations on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.72 (inspection, measuring, and test equipment). The opening words of each observation are shown on this page.
Who inspected Optikem International, Inc.?
Matthew M. Vernon is named on this Form 483, for the inspection of Jul 6 – Jul 11, 2022. Each investigator has a profile showing what they cite most.
When was Optikem International, Inc. inspected by FDA?
The inspection ran Jul 6 – Jul 11, 2022, and the Form 483 is dated July 11, 2022.
How do I get the full Form 483 for Optikem International, 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.