Chemdex, Inc.
Form 483 issued February 27, 2023 · Lenexa, Kansas
- Inspection
- Feb 21 – Feb 27, 2023
- Investigators
- Conner N. Mann· Gretchen L. Trendel· Michael C. Zubelewicz
- Observations
- 3
- Pages
- 3
- FEI number
- 1024822
In short: On February 27, 2023, FDA issued a Form 483 with 3 observations to Chemdex, Inc. in Lenexa, Kansas (FEI 1024822) after an inspection that ran Feb 21 – Feb 27, 2023. The investigators were Conner N. Mann, Gretchen L. Trendel and Michael C. Zubelewicz. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish adequate preventative maintenance schedules…
- 02
Failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture…
- 03
Failure to ensure that (b) (4)used in the final manufacturing steps of a non-sterile API intended…
This inspection in context
Conner N. Mann
7 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Kansas.
The firmChemdex, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chemdex, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Chemdex, Inc.?
Conner N. Mann, Gretchen L. Trendel and Michael C. Zubelewicz are named on this Form 483, for the inspection of Feb 21 – Feb 27, 2023. Each investigator has a profile showing what they cite most.
When was Chemdex, Inc. inspected by FDA?
The inspection ran Feb 21 – Feb 27, 2023, and the Form 483 is dated February 27, 2023.
How do I get the full Form 483 for Chemdex, 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.