ITM Medical Isotopes GmbH
Form 483 issued January 14, 2022 · Neufahrn b. Freising, Germany
- Observations
- 5
- Pages
- 2
- FEI number
- 3010531211
In short: On January 14, 2022, FDA issued a Form 483 with 5 observations to ITM Medical Isotopes GmbH in Neufahrn b. Freising, Bayern (FEI 3010531211). Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 3 of 5 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There was not all raw data of on the job training record…
- 02
Batch record not contemporaneously…
- 03
Stand alone computerize system Genie 2000 software measuring analysis for testing of purity does not have…
- 04
Documentation of inspection on…
This inspection in context
Questions about this 483
What did FDA find at ITM Medical Isotopes GmbH?
FDA listed 5 observations on this Form 483, mostly about production, quality system and materials. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was ITM Medical Isotopes GmbH inspected by FDA?
This Form 483 is dated January 14, 2022.
How do I get the full Form 483 for ITM Medical Isotopes GmbH?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.