Fresenius Kabi Compounding, LLC
FDA inspection history in Canton, Massachusetts, 2023 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2025: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–25Three Form 483s, at Canton, Massachusetts.
- 2025The longest 483 on file: 7 observations over 10 pages at Canton, Massachusetts.
Cited most
Across all Fresenius Kabi Compounding observations on file
- 21 CFR 211.42(c)(10)(iv)Design and construction features4
- 21 CFR 211.113(b)Control of microbiological contamination3
- 21 CFR 211.110(b)Sampling and testing of in-process materials and drug products2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22(d)Responsibilities of quality control unit2
The complete Fresenius Kabi Compounding file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Canton, Massachusetts
Three Form 483s · 2023 to 2025 · 16 observations
Latest: Form 483, Nov 6, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-11-06 | 483 Form 483 | Canton, Massachusetts | 7 | $99 |
| 2025-11-05 | 483 Form 483 | Canton, Massachusetts | 7 | $99 |
| 2023-03-06 | 483 Form 483 | Canton, Massachusetts | 2 | $99 |
Investigators on these documents
Jonathan G. Matrisciano (3)Daniel L. Zheng (2)Lori M. Newman (2)
FEI number 3013438665 · most recent document Nov 6, 2025
About Fresenius Kabi Compounding, LLC
How many FDA Form 483s has Fresenius Kabi Compounding, LLC received?
FDA Intel has 3 Form 483s on file for Fresenius Kabi Compounding, LLC; the most recent is dated Nov 6, 2025.
When was Fresenius Kabi Compounding, LLC last inspected by FDA?
The most recent FDA inspection document on file for Fresenius Kabi Compounding, LLC is a Form 483 dated Nov 6, 2025, for the site in Canton, Massachusetts.
What did FDA cite at Fresenius Kabi Compounding, LLC?
The regulations cited most in the observations on file for Fresenius Kabi Compounding, LLC are 21 CFR 211.42(c)(10)(iv) (Design and construction features), 4 times; 21 CFR 211.113(b) (Control of microbiological contamination), 3 times; 21 CFR 211.110(b) (Sampling and testing of in-process materials and drug products), 2 times.