Fresenius Kabi Oncology Limited
FDA inspection history in Solan, India, 2017 to 2023
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2017: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One warning letter.
- 2023One Form 483, at Solan, India.
Cited most
Across all Fresenius Kabi Oncology Limited observations on file
- 21 CFR 211.113(b)Control of microbiological contamination1
The complete Fresenius Kabi Oncology Limited file.
All 2 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
Solan, India
One Form 483 · 2023 · 1 observation
Latest: Form 483, Oct 10, 2023 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-10 | 483 Form 483 | Solan, India | 1 | $99 |
| 2017-12-18 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
FEI number 3006210232 · most recent document Oct 10, 2023
About Fresenius Kabi Oncology Limited
How many FDA Form 483s has Fresenius Kabi Oncology Limited received?
FDA Intel has 1 Form 483 on file for Fresenius Kabi Oncology Limited; the most recent is dated Oct 10, 2023.
When was Fresenius Kabi Oncology Limited last inspected by FDA?
The most recent FDA inspection document on file for Fresenius Kabi Oncology Limited is a Form 483 dated Oct 10, 2023, for the site in Solan, India.
What did FDA cite at Fresenius Kabi Oncology Limited?
The regulations cited most in the observations on file for Fresenius Kabi Oncology Limited are 21 CFR 211.113(b) (Control of microbiological contamination), 1 time.
Has Fresenius Kabi Oncology Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Fresenius Kabi Oncology Limited; the most recent is dated Dec 18, 2017.