Fresenius Kabi Compounding, LLC
Form 483 issued March 6, 2023 · Canton, Massachusetts
- Inspection
- Jan 30 – Mar 6, 2023
- Investigator
- Jonathan G. Matrisciano
- Observations
- 2
- Pages
- 3
- FEI number
- 3013438665
In short: On March 6, 2023, FDA issued a Form 483 with 2 observations to Fresenius Kabi Compounding, LLC in Canton, Massachusetts (FEI 3013438665) after an inspection that ran Jan 30 – Mar 6, 2023. The investigator was Jonathan G. Matrisciano. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.113(b) (1×) · 211.165(e) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods…
This inspection in context
Jonathan G. Matrisciano
29 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmFresenius Kabi Compounding, 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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fresenius Kabi Compounding, LLC?
FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. 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 Compounding, LLC?
Jonathan G. Matrisciano is named on this Form 483, for the inspection of Jan 30 – Mar 6, 2023. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi Compounding, LLC inspected by FDA?
The inspection ran Jan 30 – Mar 6, 2023, and the Form 483 is dated March 6, 2023.
How do I get the full Form 483 for Fresenius Kabi Compounding, 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.