G. Pohl-Boskamp GmbH & Co. KG — FDA Facility Profile

FEI 3002807915

G. Pohl-Boskamp GmbH & Co. KG is an FDA-registered facility (FEI 3002807915) located in Hohenlockstedt, DE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 7 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Sep 14, 2023: Voluntary Action Indicated (VAI)
Inspections on record
7 (6 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
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
Sep 14, 2023Voluntary Action Indicated (VAI)No citations listed
Aug 28, 2020Voluntary Action Indicated (VAI)No citations listed
Sep 15, 2017Voluntary Action Indicated (VAI)Testing and release for distribution (21 CFR 211.165(a))
Investigations of discrepancies, failures (21 CFR 211.192)
Feb 11, 2016Voluntary Action Indicated (VAI)No citations listed
Jul 3, 2015No Action Indicated (NAI)No citations listed
Feb 22, 2013Voluntary Action Indicated (VAI)Following/documenting laboratory controls (21 CFR 211.160(a))
Investigations of discrepancies, failures (21 CFR 211.192)
Nov 5, 2010Voluntary Action Indicated (VAI)Written calibration / inspection records not kept (21 CFR 211.68(a))
Complaint Handling Procedure (21 CFR 211.198(a))
Procedure Deviations Recorded and Justified (21 CFR 211.100(b))
Written record of investigation incomplete (21 CFR 211.192)

Facility details

Company
G. Pohl-Boskamp GmbH & Co. KG
Location
Hohenlockstedt (DE)
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.