Fresenius Kabi USA, LLC
Form 483 issued June 29, 2018 · Grand Island, New York
- Inspection
- Jun 25 – Jun 29, 2018
- Investigators
- Sony Mathews· William Leonard
- Observations
- 6
- Pages
- 4
- FEI number
- 3001833549
In short: On June 29, 2018, FDA issued a Form 483 with 6 observations to Fresenius Kabi USA, LLC in Grand Island, New York (FEI 3001833549) after an inspection that ran Jun 25 – Jun 29, 2018. The investigators were Sony Mathews and William Leonard. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.65 (equipment construction).
At a glance
Observations span 3 systems, led by production.
Most cited: 21 CFR 211.65 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
All records of production and control associated with a batch of drug product were not maintained…
- 03
Precisely, your firm's equipment train evaluation study assessed that stainless steel is not compatible with the…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Sony Mathews
22 documents · 2010–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmFresenius Kabi USA, LLC history
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.65
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, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.65 (equipment construction). The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA, LLC?
Sony Mathews and William Leonard are named on this Form 483, for the inspection of Jun 25 – Jun 29, 2018. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA, LLC inspected by FDA?
The inspection ran Jun 25 – Jun 29, 2018, and the Form 483 is dated June 29, 2018.
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.