Dharma Research, Inc. – FDA Inspection, Mar 18, 2019

Record Details

This FDA Inspection record concerns Dharma Research, Inc., with an inspection on March 18, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: Dharma Research, Inc.
Inspection Date: March 18, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Dianiris C. Ayala

View Company Profile

ID · da8c66b3-04b4-4caa-8b68-cb95f91ea4a2

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1083281
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.40Lack of procedures, or not maintained
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.70(a)Production processes

Showing 10 of 12 citations.

Full citation text and observation details available on the Dashboard.

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
November 1, 2016	VAI	Center for Drug Evaluation and Research	Unapproved and Misbranded Drugs
September 12, 2014	VAI	Center for Devices and Radiological Health	Compliance: Devices