Delpharm Huningue FDA Inspection Record

FEI 3003157245 · Inspections, Form 483s, warning letters and import refusals

Delpharm Huningue is an FDA-registered facility (FEI 3003157245) located in -Select State- FRA68330, FR. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Nov 30, 2023: Voluntary Action Indicated (VAI)
Inspections on record
6 (3 VAI, 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
Import refusals
6

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 30, 2023Voluntary Action Indicated (VAI)No citations listed
Aug 8, 2019Voluntary Action Indicated (VAI)No citations listed
Jun 22, 2018No Action Indicated (NAI)No citations listed
Sep 23, 2016No Action Indicated (NAI)No citations listed
Dec 19, 2014No Action Indicated (NAI)No citations listed
Dec 15, 2011Voluntary Action Indicated (VAI)Calibration/Inspection/Checking not done (21 CFR 211.68(a))
Procedures for non-sterile drug products (21 CFR 211.113(a))
Establish reliability of supplier's C of A (21 CFR 211.84(d)(2))

Facility details

Company
Delpharm Huningue S.A.S.
Location
-Select State- FRA68330 (FR)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

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