Remington Medical, S.A. — FDA Facility Profile

FEI 3009265194

Remington Medical, S.A. is an FDA-registered facility (FEI 3009265194) located in Santo Domingo Este Santo Domingo, DO. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Aug 30, 2018: No Action Indicated (NAI)
Inspections on record
3 (1 OAI, 2 NAI)
Last OAI inspection
Aug 14, 2014
Warning letters
1 listed by FDA for this FEI, latest Sep 14, 2015
Import refusals
3

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
Aug 30, 2018No Action Indicated (NAI)No citations listed
Jun 25, 2015No Action Indicated (NAI)No citations listed
Aug 14, 2014Official Action Indicated (OAI)Training - Lack of or inadequate procedures (21 CFR 820.25(b))
Lack of or inadequate procedures (21 CFR 820.100(a))
Maintenance schedule, Lack of or inadequate schedule (21 CFR 820.70(g)(1))
Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a))
and 5 more

Facility details

Company
REMINGTON MEDICAL, S.A.
Location
Santo Domingo Este Santo Domingo (DO)
Source
device

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