XeCare LLC
Form 483 issued June 17, 2026 · New Albany, Ohio
- Inspection
- Jun 8 – Jun 17, 2026
- Investigators
- Kara J. Wright· Logan T. Williams
- Observations
- 3
- Pages
- 4
- FEI number
- 3017865039
In short: On June 17, 2026, FDA issued a Form 483 with 3 observations to XeCare LLC in New Albany, Ohio (FEI 3017865039) after an inspection that ran Jun 8 – Jun 17, 2026. The investigators were Kara J. Wright and Logan T. Williams. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Facilities & equipment and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or…
- 02
Materials were exposed to lower than…
- 03
Use of ingredients not intended for pharmaceutical use…
This inspection in context
Kara J. Wright
9 documents · 2024–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
The firmXeCare LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at XeCare LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected XeCare LLC?
Kara J. Wright and Logan T. Williams are named on this Form 483, for the inspection of Jun 8 – Jun 17, 2026. Each investigator has a profile showing what they cite most.
When was XeCare LLC inspected by FDA?
The inspection ran Jun 8 – Jun 17, 2026, and the Form 483 is dated June 17, 2026.
How do I get the full Form 483 for XeCare LLC?
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.