Rhausler Inc
Form 483 issued December 20, 2024 · Fremont, California
- Inspection
- Dec 10 – Dec 20, 2024
- Investigator
- Kenya Destin
- Observations
- 6
- Pages
- 6
- FEI number
- 3007210720
In short: On December 20, 2024, FDA issued a Form 483 with 6 observations to Rhausler Inc in Fremont, California (FEI 3007210720) after an inspection that ran Dec 10 – Dec 20, 2024. The investigator was Kenya Destin. Most observations concern management controls and cAPA; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
4 of 6 observations on this 483 concern management controls.
What FDA observed
Preview: the opening words of each observation- 01
Quality system procedures and instructions…
- 02
Collective and preventive action activities and/or results have…
- 03
Procediues for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Quality audits have not…
This inspection in context
Kenya Destin
3 documents · 2023–2024
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in California.
The firmRhausler Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rhausler Inc?
FDA listed 6 observations on this Form 483, mostly about management controls and cAPA. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected Rhausler Inc?
Kenya Destin is named on this Form 483, for the inspection of Dec 10 – Dec 20, 2024. Each investigator has a profile showing what they cite most.
When was Rhausler Inc inspected by FDA?
The inspection ran Dec 10 – Dec 20, 2024, and the Form 483 is dated December 20, 2024.
How do I get the full Form 483 for Rhausler Inc?
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.