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R82 A/S — FDA Facility Profile

FEI 3001657382

R82 A/S is an FDA-registered facility (FEI 3001657382) located in GEDVED Midtjylland, DK. RegDataLab tracks 3 FDA inspections and 2 compliance actions at this facility.

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What FDA found at this site

Latest inspection
Nov 1, 2018: Voluntary Action Indicated (VAI)
Inspections on record
3 (1 OAI, 2 VAI)
Last OAI inspection
Jun 7, 2013
Warning letters
2 listed by FDA for this FEI, latest Oct 18, 2013
Recalls as the recalling firm
4, latest Dec 8, 2021
Import refusals
2

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Nov 1, 2018Voluntary Action Indicated (VAI)Service reports (21 CFR 820.200(d))
Production and Process Change Procedures, lack of or Inad. (21 CFR 820.70(b))
Jun 7, 2013Official Action Indicated (OAI)No citations listed
Oct 7, 2010Voluntary Action Indicated (VAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Dec 8, 2021Not yet classifiedZ-0569-2022R82 by ETAC Push Brace for High-Low
The chrome surface of the push brace can crack during use, potentially cutting the user.
Mar 6, 2020Not yet classifiedZ-1858-2020Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up…
The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool.
Mar 28, 2019Not yet classifiedZ-1315-2019Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00…
Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
Jun 30, 2017Not yet classifiedZ-0441-2019Heron toilet and bath chair Model 880505-01 & 880505-11
Replacement campaign on all units that have a gas spring head in aluminum.

Facility details

Company
R82 A/S
Location
GEDVED Midtjylland (DK)
Source
device

Compliance actions

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.