Corden Pharma Boulder, Inc.
Form 483 issued February 6, 2019 · Boulder, Colorado
- Inspection
- Jan 30 – Feb 6, 2019
- Investigator
- Nayan J. Patel
- Observations
- 1
- Pages
- 2
- FEI number
- 1710165
In short: On February 6, 2019, FDA issued a Form 483 with 1 observation to Corden Pharma Boulder, Inc. in Boulder, Colorado (FEI 1710165) after an inspection that ran Jan 30 – Feb 6, 2019. The investigator was Nayan J. Patel. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Deviations from written test…
This inspection in context
Nayan J. Patel
11 documents · 2017–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Utah.
The firmCorden Pharma Boulder, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Corden Pharma Boulder, Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Corden Pharma Boulder, Inc.?
Nayan J. Patel is named on this Form 483, for the inspection of Jan 30 – Feb 6, 2019. Each investigator has a profile showing what they cite most.
When was Corden Pharma Boulder, Inc. inspected by FDA?
The inspection ran Jan 30 – Feb 6, 2019, and the Form 483 is dated February 6, 2019.
How do I get the full Form 483 for Corden Pharma Boulder, 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.