Roche Diagnostics GmbH
Form 483 issued March 10, 2023 · Penzberg, Germany
- Inspection
- Mar 2 – Mar 10, 2023
- Investigators
- Kyunghun Park· Michael R. Shanks· Shadia Zaman
- Observations
- 2
- Pages
- 1
- FEI number
- 3002806560
In short: On March 10, 2023, FDA issued a Form 483 with 2 observations to Roche Diagnostics GmbH in Penzberg, Germany (FEI 3002806560) after an inspection that ran Mar 2 – Mar 10, 2023. The investigators were Kyunghun Park, Michael R. Shanks and Shadia Zaman. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.182 (equipment cleaning and use log).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.182 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment validation is not…
- 02
Document Control is not…
This inspection in context
Kyunghun Park
1 document · 2023
Cites 211.182 (equipment cleaning and use log) more than any other section. Most of their documents are for sites in Germany.
The firmRoche Diagnostics GmbH history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Roche Diagnostics GmbH?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.182 (equipment cleaning and use log). The opening words of each observation are shown on this page.
Who inspected Roche Diagnostics GmbH?
Kyunghun Park, Michael R. Shanks and Shadia Zaman are named on this Form 483, for the inspection of Mar 2 – Mar 10, 2023. Each investigator has a profile showing what they cite most.
When was Roche Diagnostics GmbH inspected by FDA?
The inspection ran Mar 2 – Mar 10, 2023, and the Form 483 is dated March 10, 2023.
How do I get the full Form 483 for Roche Diagnostics 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.