ANTARMA LLC — FDA Facility Profile

FEI 3014117096

ANTARMA LLC is an FDA-registered facility (FEI 3014117096) located in New York, NY, US. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Sep 23, 2022: No Action Indicated (NAI)
Inspections on record
2 (2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

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
Sep 23, 2022No Action Indicated (NAI)Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50)
Jun 7, 2019No Action Indicated (NAI)Procedures not adequately established or maintained (21 CFR 820.40)
Design control - no procedures (21 CFR 820.30(a))
Design input - documentation (21 CFR 820.30(c))
Design review - Lack of or inadequate procedures (21 CFR 820.30(e))
and 3 more

Facility details

Company
Antarma LLC
Location
New York, NY (US)
Source
device

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