Dmg Chemisch Pharmazeutische Fabrik GmbH

FDA Regulatory Profile

Dmg Chemisch Pharmazeutische Fabrik GmbH has 0 FDA recalls, 2 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 1, 2018 · NAI
Latest 510(k)
Jun 1, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances4Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 1, 2018Hamburg, GermanyDevicesNo Action Indicated (NAI)3004150030
Dec 2, 2008Hamburg, GermanyDevicesNo Action Indicated (NAI)3004150030

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K213201DeltaFil, DeltaFil ConditionerJun 1, 2022
K183337LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2May 29, 2019
K991172IONOSIT BONDMay 17, 1999
K924830LUXATEMP AUTOMIXApr 29, 1994