Tarmac Products, Inc. – FDA Inspection, Sep 27, 2019

Record Details

This FDA Inspection record concerns Tarmac Products, Inc., with an inspection on September 27, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Tarmac Products, Inc.
Inspection Date: September 27, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: Jennifer L. Huntington (FDA Associated Person)
Karen M. Cruz Arenas (Issuing Officer)

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ID · d38f8256-19fe-4d2e-b212-85fed7b5ff50

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1102996
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued
Enforcement: Warning Letter

FDA Citations

21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 211.63Equipment Design, Size and Location
21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.194(a)Complete test data included in records
21 CFR 211.198(a)Procedures to be written and followed
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ

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Other FDA inspections of Tarmac Products, Inc.

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February 6, 2026	VAI	Florida District Office	Drug Quality Assurance
November 4, 2025	VAI	Florida District Office	Compliance: Medical Devices
July 22, 2022	VAI	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