FAREVA Unterach GmbH
Form 483 issued May 8, 2019 · Unterach am Attersee, Austria
- Inspection
- Apr 29 – May 8, 2019
- Investigator
- William Leonard
- Observations
- 2
- Pages
- 2
- FEI number
- 3002829723
In short: On May 8, 2019, FDA issued a Form 483 with 2 observations to FAREVA Unterach GmbH in Unterach am Attersee, Austria (FEI 3002829723) after an inspection that ran Apr 29 – May 8, 2019. The investigator was William Leonard. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(b) (1×) · 211.166(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
- 02
The written stability testing program is not followed. Electronic records are used, but they do not…
This inspection in context
William Leonard
17 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmFAREVA Unterach 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 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FAREVA Unterach GmbH?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected FAREVA Unterach GmbH?
William Leonard is named on this Form 483, for the inspection of Apr 29 – May 8, 2019. Each investigator has a profile showing what they cite most.
When was FAREVA Unterach GmbH inspected by FDA?
The inspection ran Apr 29 – May 8, 2019, and the Form 483 is dated May 8, 2019.
How do I get the full Form 483 for FAREVA Unterach 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.