Calumet Karns City Refining LLC
Form 483 issued December 4, 2024 · Karns City, Pennsylvania
- Inspection
- Dec 2 – Dec 4, 2024
- Investigator
- Kara J. Wright
- Observations
- 9
- Pages
- 7
- FEI number
- 2517666
In short: On December 4, 2024, FDA issued a Form 483 with 9 observations to Calumet Karns City Refining LLC in Karns City, Pennsylvania (FEI 2517666) after an inspection that ran Dec 2 – Dec 4, 2024. The investigator was Kara J. Wright. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 6 of 9 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in laboratory…
- 02
Failure to have laboratory control records that include complete data derived from all laboratory tests conducted…
- 03
Facilities and Equipment used in the manufacture, processing, packing or holding of drug substances are unavailable…
- 04
Failure of your quality unit to exercise its responsibility to ensure the APIs manufactured at your…
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 firmCalumet Karns City Refining LLC 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 Calumet Karns City Refining LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. 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 Calumet Karns City Refining LLC?
Kara J. Wright is named on this Form 483, for the inspection of Dec 2 – Dec 4, 2024. Each investigator has a profile showing what they cite most.
When was Calumet Karns City Refining LLC inspected by FDA?
The inspection ran Dec 2 – Dec 4, 2024, and the Form 483 is dated December 4, 2024.
How do I get the full Form 483 for Calumet Karns City Refining 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.