Fresenius Kabi USA LLC
Form 483 issued May 18, 2020 · Melrose Park, Illinois
- Inspection
- Apr 30 – May 18, 2020
- Investigators
- Brian D. Nicholson· Michele L. Glendenning
- Observations
- 6
- Pages
- 5
- FEI number
- 1450022
In short: On May 18, 2020, FDA issued a Form 483 with 6 observations to Fresenius Kabi USA LLC in Melrose Park, Illinois (FEI 1450022) after an inspection that ran Apr 30 – May 18, 2020. The investigators were Brian D. Nicholson and Michele L. Glendenning. Most observations concern production and quality system.
At a glance
Production and quality system account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedmes applicable to the quality control unit are not in…
- 02
Written procedmes are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
EMPI.OYEE(S) SIGNATURE The batch production and control records are deficient in that they do not include…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmFresenius Kabi USA LLC history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
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, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA LLC?
Brian D. Nicholson and Michele L. Glendenning are named on this Form 483, for the inspection of Apr 30 – May 18, 2020. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA LLC inspected by FDA?
The inspection ran Apr 30 – May 18, 2020, and the Form 483 is dated May 18, 2020.
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.