Dharma Research, Inc. – FDA Inspection, Sep 12, 2014

Record Details

This FDA Inspection record concerns Dharma Research, Inc., with an inspection on September 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Dharma Research, Inc.
Inspection Date: September 12, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · aee2b4c7-2398-4ebe-816a-585dd1352936

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 893744
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.40Procedures not adequately established or maintained
21 CFR 820.25(b)Training records
21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.184DHR content

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Other FDA inspections of Dharma Research, Inc.

Date	Classification	Office	Project area
March 13, 2026	VAI	Florida District Office	Compliance: Medical Devices
December 11, 2024	VAI	Florida District Office	Compliance: Medical Devices
September 30, 2022	VAI	Center for Drug Evaluation and Research	Unapproved and Misbranded Drugs
March 18, 2019	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
November 1, 2016	VAI	Center for Drug Evaluation and Research	Unapproved and Misbranded Drugs