Labor Augsburg MVZ GmbH
Form 483 issued May 9, 2025 · Augsburg, Germany
- Inspection
- May 5 – May 9, 2025
- Investigator
- Melkamu Getie-Kebtie
- Observations
- 2
- Pages
- 2
- FEI number
- 3036040213
In short: On May 9, 2025, FDA issued a Form 483 with 2 observations to Labor Augsburg MVZ GmbH in Augsburg, Germany (FEI 3036040213) after an inspection that ran May 5 – May 9, 2025. The investigator was Melkamu Getie-Kebtie. Most observations concern clinical (BIMO).
At a glance
2 of 2 observations on this 483 concern clinical (bimo).
What FDA observed
Preview: the opening words of each observation- 01
The fimi did not adhere to their established acceptance criterion for individual quality control samples in…
- 02
The film did not retain the electronic source data (i.e., Cobas 6000 instrument generated readings [electrochemiluminescence…
This inspection in context
Questions about this 483
What did FDA find at Labor Augsburg MVZ GmbH?
FDA listed 2 observations on this Form 483, mostly about clinical (BIMO). The opening words of each observation are shown on this page.
Who inspected Labor Augsburg MVZ GmbH?
Melkamu Getie-Kebtie is named on this Form 483, for the inspection of May 5 – May 9, 2025. Each investigator has a profile showing what they cite most.
When was Labor Augsburg MVZ GmbH inspected by FDA?
The inspection ran May 5 – May 9, 2025, and the Form 483 is dated May 9, 2025.
How do I get the full Form 483 for Labor Augsburg MVZ 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.