ITM Medical Isotopes GmbH
FDA inspection history in Neufahrn b. Freising, Germany, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Neufahrn b. Freising, Germany.
Cited most
Across all ITM Medical Isotopes observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.184Component, drug product container, closure, and labeling records1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.25Personnel qualifications1
The complete ITM Medical Isotopes file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Neufahrn b. Freising, Germany
One Form 483 · 2022
Latest: Form 483, Jan 14, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-01-14 | 483 Form 483 | Neufahrn b. Freising, Germany | — | $99 |
FEI number 3010531211 · most recent document Jan 14, 2022
About ITM Medical Isotopes GmbH
How many FDA Form 483s has ITM Medical Isotopes GmbH received?
FDA Intel has 1 Form 483 on file for ITM Medical Isotopes GmbH; the most recent is dated Jan 14, 2022.
When was ITM Medical Isotopes GmbH last inspected by FDA?
The most recent FDA inspection document on file for ITM Medical Isotopes GmbH is a Form 483 dated Jan 14, 2022, for the site in Neufahrn b. Freising, Germany.
What did FDA cite at ITM Medical Isotopes GmbH?
The regulations cited most in the observations on file for ITM Medical Isotopes GmbH are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.184 (Component, drug product container, closure, and labeling records), 1 time; 21 CFR 211.188 (Batch production and control records), 1 time.