PHX Reporter

There were six companies in cities associated with Maricopa County that received FDA citations as a result of six inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 20% increase over the number of companies cited in the previous quarter.

The citations in the county include:

• The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.
• Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system.
• Quality audits have not been performed.

All of the companies cited were involved in either Devices or Drugs sectors.

Of the companies cited, two should take voluntary actions to correct their managing operations (33.3%). Additionally, two companies had to take regulatory and/or administrative actions (33.3%).

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
Abraxis Bioscience, LLC	Drugs	10/06/2023	Procedures not in writing, fully followed
Abraxis Bioscience, LLC	Drugs	10/06/2023	Equipment to control conditions
Abraxis Bioscience, LLC	Drugs	10/06/2023	input/output verification
Abraxis Bioscience, LLC	Drugs	10/06/2023	Annual visual exams of drug products
Abraxis Bioscience, LLC	Drugs	10/06/2023	Written record of investigation incomplete
Abraxis Bioscience, LLC	Drugs	10/06/2023	Second person sign off
AnuMed International, LLC	Drugs	11/07/2023	Procedures not in writing, fully followed
AnuMed International, LLC	Drugs	11/07/2023	Sanitation--buildings not clean, free of infestation
AnuMed International, LLC	Drugs	11/07/2023	Absence of Written Procedures
AnuMed International, LLC	Drugs	11/07/2023	Scientifically sound laboratory controls
AnuMed International, LLC	Drugs	11/07/2023	Adequate number of batches on stability
AnuMed International, LLC	Drugs	11/07/2023	Prepared for each batch, include complete information
Neuromechanical Innovations, LLC	Devices	12/13/2023	Label to bear a unique device identifier
Neuromechanical Innovations, LLC	Devices	12/13/2023	Management review - defined interval, sufficient frequency
Neuromechanical Innovations, LLC	Devices	12/13/2023	Quality Audit/Reaudit - conducted
Noraxon USA, Inc.	Devices	11/30/2023	Calibration procedures - content
Signature Formulations, LLC	Drugs	11/22/2023	Lack of quality control unit
Signature Formulations, LLC	Drugs	11/22/2023	Absence of Written Procedures
Signature Formulations, LLC	Drugs	11/22/2023	Lab controls established, including changes
Signature Formulations, LLC	Drugs	11/22/2023	Testing and release for distribution
Signature Formulations, LLC	Drugs	11/22/2023	Written program not followed
Signature Formulations, LLC	Drugs	11/22/2023	Procedures to be written and followed
TAMA Research Corporation	Devices	10/05/2023	Records of complaint investigation
TAMA Research Corporation	Devices	10/05/2023	Devices subject to device identification GUDID data submission requirements.