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FENWAL INTERNATIONAL, INC. FDA Inspection Record

FEI 1000222291 · Inspections, Form 483s, warning letters and import refusals

FENWAL INTERNATIONAL, INC. is an FDA-registered facility (FEI 1000222291) located in San German, PR, US. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Mar 21, 2016: No Action Indicated (NAI)
Inspections on record
3 (3 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
Mar 21, 2016No Action Indicated (NAI)No citations listed
Feb 13, 2013No Action Indicated (NAI)No citations listed
Mar 17, 2011No Action Indicated (NAI)No citations listed

Facility details

Company
Fenwal International Inc.
Location
San German, PR (US)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE
Source
both

FDA data resources

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