Medacta International, SA
Form 483 issued November 19, 2024 · Ticino, Switzerland
- Inspection
- Nov 11 – Nov 19, 2024
- Observations
- 1
- Pages
- 3
- FEI number
- 3005180920
In short: On November 19, 2024, FDA issued a Form 483 with 1 observation to Medacta International, SA in Ticino, Switzerland (FEI 3005180920) after an inspection that ran Nov 11 – Nov 19, 2024. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Questions about this 483
What did FDA find at Medacta International, SA?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
When was Medacta International, SA inspected by FDA?
The inspection ran Nov 11 – Nov 19, 2024, and the Form 483 is dated November 19, 2024.
How do I get the full Form 483 for Medacta International, SA?
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.