Fresenius Kabi USA, LLC
Form 483 issued June 13, 2023 · Wilson, North Carolina
- Inspection
- Jun 5 – Jun 13, 2023
- Investigator
- Brittny C. Cargo
- Observations
- 6
- Pages
- 6
- FEI number
- 3008887707
In short: On June 13, 2023, FDA issued a Form 483 with 6 observations to Fresenius Kabi USA, LLC in Wilson, North Carolina (FEI 3008887707) after an inspection that ran Jun 5 – Jun 13, 2023. The investigator was Brittny C. Cargo. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
4 of 6 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and standards designed…
This inspection in context
Brittny C. Cargo
14 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Louisiana.
The firmFresenius Kabi USA, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fresenius Kabi USA, LLC?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA, LLC?
Brittny C. Cargo is named on this Form 483, for the inspection of Jun 5 – Jun 13, 2023. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA, LLC inspected by FDA?
The inspection ran Jun 5 – Jun 13, 2023, and the Form 483 is dated June 13, 2023.
How do I get the full Form 483 for Fresenius Kabi USA, 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.