Tarmac Products, Inc. – FDA Inspection, Nov 4, 2025

Record Details

This FDA Inspection record concerns Tarmac Products, Inc., with an inspection on November 4, 2025, issued by the Florida District Office, covering medical devices & rad health.

Company: Tarmac Products, Inc.
Inspection Date: November 4, 2025
Product Type: Medical Devices & Rad Health
Office: Florida District Office
Person: Ebony D. Sanon (Issuing Officer)

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ID · 0526d86e-0077-45e3-879f-222e15e7496e

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1283730
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 820.22Quality Audits - defined intervals
21 CFR 820.20(c)Management review - defined interval, sufficient frequency
21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
21 CFR 803.17(a)(1)Lack of System for Event Evaluations
21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
21 CFR 801.20(a)Label to bear a unique device identifier

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Other FDA inspections of Tarmac Products, Inc.

Date	Classification	Office	Project area
February 6, 2026	VAI	Florida District Office	Drug Quality Assurance
July 22, 2022	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
September 27, 2019	OAI	Center for Drug Evaluation and Research	Drug Quality Assurance
November 10, 2017	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
January 8, 2015	VAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ