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OPELLA HEALTHCARE INTERNATIONAL SAS FDA Inspection Record

FEI 3003492806 · Inspections, Form 483s, warning letters and import refusals

OPELLA HEALTHCARE INTERNATIONAL SAS is an FDA-registered facility (FEI 3003492806) located in Compiegne, FR. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL; REPACK. RegDataLab tracks 6 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jan 10, 2025: Voluntary Action Indicated (VAI)
Inspections on record
6 (5 VAI, 1 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
Import refusals
8

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
Jan 10, 2025Voluntary Action Indicated (VAI)No citations listed
Oct 31, 2019Voluntary Action Indicated (VAI)No citations listed
Jun 23, 2017Voluntary Action Indicated (VAI)Training , Education , Experience overall (21 CFR 211.25(a))
Equipment Design, Size and Location (21 CFR 211.63)
Procedures for non-sterile drug products (21 CFR 211.113(a))
Complete Test Data (21 CFR 211.194(a)(4))
Sep 18, 2015Voluntary Action Indicated (VAI)Following/documenting laboratory controls (21 CFR 211.160(a))
Investigations of discrepancies, failures (21 CFR 211.192)
Complaint Handling Procedure (21 CFR 211.198(a))
Scientifically sound laboratory controls (21 CFR 211.160(b))
and 1 more
Sep 19, 2013Voluntary Action Indicated (VAI)No citations listed
Oct 21, 2011No Action Indicated (NAI)No citations listed

Facility details

Company
Opella Healthcare International SAS
Location
Compiegne (FR)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL; REPACK
Source
decrs

Import refusals

FDA data resources

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