KDC/ONE Development Corporation, Inc.
Form 483 issued January 27, 2023 · Knowlton, Canada
- Inspection
- Jan 23 – Jan 27, 2023
- Investigator
- Kham Phommachanh
- Observations
- 2
- Pages
- 1
- FEI number
- 3003690512
In short: On January 27, 2023, FDA issued a Form 483 with 2 observations to KDC/ONE Development Corporation, Inc. in Knowlton, Quebec (FEI 3003690512) after an inspection that ran Jan 23 – Jan 27, 2023. The investigator was Kham Phommachanh. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and production account for 2 of 2 observations.
Most cited: 21 CFR 211.194(a)(7) (1×) · 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records do not include the initials or signature of the person who performs each test…
- 02
Deviations from written production and process control procedures are…
This inspection in context
Kham Phommachanh
12 documents · 2009–2024
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in Canada.
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(a)(7)
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 and production. 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.?
Kham Phommachanh is named on this Form 483, for the inspection of Jan 23 – Jan 27, 2023. Each investigator has a profile showing what they cite most.
When was KDC/ONE Development Corporation, Inc. inspected by FDA?
The inspection ran Jan 23 – Jan 27, 2023, and the Form 483 is dated January 27, 2023.
How do I get the full Form 483 for KDC/ONE Development Corporation, Inc.?
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