Warning letter

Medical Components, Inc dba MedComp: warning letter of Apr 2, 2015

FDA warning letter 454607 · Philadelphia District Office

Key facts

Reference number 454607
Company Medical Components, Inc dba MedComp
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Apr 2, 2015
Posted date Apr 21, 2015
Issuing office Philadelphia District Office
Product type Devices
CFR sections cited 820
Inspection city Harleysville
Inspection ZIP 19438
Inspection start date Jan 13, 2015
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

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