Fresenius Kabi Oncology Limited
Form 483 issued October 10, 2023 · Solan, India
- Inspection
- Oct 3 – Oct 10, 2023
- Investigators
- Anastasia M. Shields· Justin A. Boyd
- Observations
- 1
- Pages
- 10
- FEI number
- 3006210232
In short: On October 10, 2023, FDA issued a Form 483 with 1 observation to Fresenius Kabi Oncology Limited in Solan, Himachal Pradesh (FEI 3006210232) after an inspection that ran Oct 3 – Oct 10, 2023. The investigators were Anastasia M. Shields and Justin A. Boyd. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (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 established…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmFresenius Kabi Oncology Limited history
All 2 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 Oncology Limited?
FDA listed 1 observation on this Form 483, mostly about production. 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 Oncology Limited?
Anastasia M. Shields and Justin A. Boyd are named on this Form 483, for the inspection of Oct 3 – Oct 10, 2023. Each investigator has a profile showing what they cite most.
When was Fresenius Kabi Oncology Limited inspected by FDA?
The inspection ran Oct 3 – Oct 10, 2023, and the Form 483 is dated October 10, 2023.
How do I get the full Form 483 for Fresenius Kabi Oncology Limited?
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