HTO Nevada Inc – FDA Inspection, Jun 24, 2015

Record Details

This FDA Inspection record concerns HTO Nevada Inc, with an inspection on June 24, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: HTO Nevada Inc
Inspection Date: June 24, 2015
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · f45ae49a-d61a-4bdc-8e5f-28b9f3a8e2de

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 933396
FDA center: Human Drugs
Project area: Unapproved and Misbranded Drugs

FDA Citations

21 CFR 211.28(a)Clothing appropriate for duties performed
21 CFR 211.110(a)Control procedures to monitor and validate performance
21 CFR 211.130Procedures are written, and followed
21 CFR 211.113(a)Procedures for non-sterile drug products
21 CFR 211.68(a)Calibration/Inspection/Checking not done
21 CFR 211.125(a)Strict control not exercised over labeling issued
21 CFR 211.192Written record of investigation incomplete

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Other FDA inspections of HTO Nevada Inc

Date	Classification	Office	Project area
August 22, 2025	OAI	Seattle District Office	Drug Quality Assurance
August 17, 2023	VAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ
March 15, 2019	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
April 2, 2018	NAI	Center for Food Safety and Applied Nutrition	Foodborne Biological Hazards
April 14, 2017	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance