KDC/ONE Development Corporation, Inc.
Form 483 issued September 21, 2017 · Knowlton, Canada
- Inspection
- Sep 18 – Sep 21, 2017
- Investigator
- Emily J. Orban
- Observations
- 2
- Pages
- 1
- FEI number
- 3003690512
In short: On September 21, 2017, FDA issued a Form 483 with 2 observations to KDC/ONE Development Corporation, Inc. in Knowlton, Quebec (FEI 3003690512) after an inspection that ran Sep 18 – Sep 21, 2017. The investigator was Emily J. Orban. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 02
Original records are not reviewed for accuracy, completeness, and…
This inspection in context
Emily J. Orban
19 documents · 2012–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Michigan.
The firmKDC/ONE Development Corporation, 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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KDC/ONE Development Corporation, Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected KDC/ONE Development Corporation, Inc.?
Emily J. Orban is named on this Form 483, for the inspection of Sep 18 – Sep 21, 2017. Each investigator has a profile showing what they cite most.
When was KDC/ONE Development Corporation, Inc. inspected by FDA?
The inspection ran Sep 18 – Sep 21, 2017, and the Form 483 is dated September 21, 2017.
How do I get the full Form 483 for KDC/ONE Development Corporation, 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.