Roche Diagnostics GmbH
Form 483 issued August 29, 2019 · Mannheim, Germany
- Inspection
- Aug 26 – Aug 29, 2019
- Observations
- 1
- Pages
- 4
- FEI number
- 3002806559
In short: On August 29, 2019, FDA issued a Form 483 with 1 observation to Roche Diagnostics GmbH in Mannheim, Germany (FEI 3002806559) after an inspection that ran Aug 26 – Aug 29, 2019. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.50 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
This inspection in context
Questions about this 483
What did FDA find at Roche Diagnostics GmbH?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
When was Roche Diagnostics GmbH inspected by FDA?
The inspection ran Aug 26 – Aug 29, 2019, and the Form 483 is dated August 29, 2019.
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.