Fresenius Kabi USA, LLC
Form 483 issued February 4, 2016 · Grand Island, New York
- Inspection
- Jan 27 – Feb 4, 2016
- Investigators
- Charanjeet S. Jassal· Patric C. Klotzbuecher
- Observations
- 5
- Pages
- 5
- FEI number
- 3001833549
In short: On February 4, 2016, FDA issued a Form 483 with 5 observations to Fresenius Kabi USA, LLC in Grand Island, New York (FEI 3001833549) after an inspection that ran Jan 27 – Feb 4, 2016. The investigators were Charanjeet S. Jassal and Patric C. Klotzbuecher. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
4 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Employees engaged in the manufacture of a drug product lack the training required to…
This inspection in context
Charanjeet S. Jassal
5 documents · 2015–2016
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fresenius Kabi USA, LLC?
FDA listed 5 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi USA, LLC?
Charanjeet S. Jassal and Patric C. Klotzbuecher are named on this Form 483, for the inspection of Jan 27 – Feb 4, 2016. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi USA, LLC inspected by FDA?
The inspection ran Jan 27 – Feb 4, 2016, and the Form 483 is dated February 4, 2016.
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.