Fresenius Kabi Compounding, LLC
Form 483 issued November 5, 2025 · Canton, Massachusetts
- Inspection
- Oct 9 – Nov 5, 2025
- Investigators
- Daniel L. Zheng· Jonathan G. Matrisciano· Lori M. Newman
- Observations
- 7
- Pages
- 10
- FEI number
- 3013438665
In short: On November 5, 2025, FDA issued a Form 483 with 7 observations to Fresenius Kabi Compounding, LLC in Canton, Massachusetts (FEI 3013438665) after an inspection that ran Oct 9 – Nov 5, 2025. The investigators were Daniel L. Zheng, Jonathan G. Matrisciano and Lori M. Newman. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile are not…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Your examination and testing of samples did not assure that the drug product and in-process…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
Cites 211.192 (production record review) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fresenius Kabi Compounding, LLC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Fresenius Kabi Compounding, LLC?
Daniel L. Zheng, Jonathan G. Matrisciano and Lori M. Newman are named on this Form 483, for the inspection of Oct 9 – Nov 5, 2025. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi Compounding, LLC inspected by FDA?
The inspection ran Oct 9 – Nov 5, 2025, and the Form 483 is dated November 5, 2025.
How do I get the full Form 483 for Fresenius Kabi Compounding, LLC?
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