CeramTec GmbH Medical Products Division
Form 483 issued January 19, 2023
- Inspection
- Jan 16 – Jan 19, 2023
- Observations
- 2
- Pages
- 1
- FEI number
- 3001278222
In short: On January 19, 2023, FDA issued a Form 483 with 2 observations to CeramTec GmbH Medical Products Division (FEI 3001278222) after an inspection that ran Jan 16 – Jan 19, 2023. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
Production & process controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.75 (1×) · 803.17 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Written MDR procedures have not been…
This inspection in context
Questions about this 483
What did FDA find at CeramTec GmbH Medical Products Division?
FDA listed 2 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
When was CeramTec GmbH Medical Products Division inspected by FDA?
The inspection ran Jan 16 – Jan 19, 2023, and the Form 483 is dated January 19, 2023.
How do I get the full Form 483 for CeramTec GmbH Medical Products Division?
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.