Tecomet, Inc.
Form 483 issued November 15, 2019 · Boulder, Colorado
- Inspection
- Oct 22 – Nov 15, 2019
- Investigator
- Christine I. Shaw
- Observations
- 1
- Pages
- 12
- FEI number
- 3007137928
In short: On November 15, 2019, FDA issued a Form 483 with 1 observation to Tecomet, Inc. in Boulder, Colorado (FEI 3007137928) after an inspection that ran Oct 22 – Nov 15, 2019. The investigator was Christine I. Shaw. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Christine I. Shaw
8 documents · 2016–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Colorado.
The firmTecomet, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tecomet, Inc.?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Tecomet, Inc.?
Christine I. Shaw is named on this Form 483, for the inspection of Oct 22 – Nov 15, 2019. Each investigator has a profile showing what they cite most.
When was Tecomet, Inc. inspected by FDA?
The inspection ran Oct 22 – Nov 15, 2019, and the Form 483 is dated November 15, 2019.
How do I get the full Form 483 for Tecomet, 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.