SE Valley Times

There were 27 companies in cities associated with Maricopa County that received FDA citations as a result of 27 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 3.8% increase over the number of companies cited in the previous year.

Of the 78 citations issued, the most common citations were 'Quality audits have not been performed' and 'Records of complaint investigations do not include required information'.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.

Of the companies cited, 22 should take voluntary actions to correct their managing operations (81.5%). Additionally, three companies had to take regulatory and/or administrative actions (11.1%).

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
DentiMax, Inc.	Devices	03/10/2023	Documented evaluation
DentiMax, Inc.	Devices	03/10/2023	Records of complaint investigation
Everkrisp Vegetables, Inc.	Food and Cosmetics	06/14/2023	Storage and Distribution
Ganfer Fresh, LLC	Food and Cosmetics	01/26/2023	Develop FSVP
Gergens Orthodontic Lab, Inc.	Devices	03/30/2023	Quality Audit/Reaudit - conducted
Global Vitality, Inc.	Food and Cosmetics	05/18/2023	Specifications - component identity
Global Vitality, Inc.	Food and Cosmetics	05/18/2023	Specifications-component purity, strength, composition
Global Vitality, Inc.	Food and Cosmetics	05/18/2023	Specifications - contamination limits
Global Vitality, Inc.	Food and Cosmetics	05/18/2023	Specifications - identity, purity, strength, composition
Global Vitality, Inc.	Food and Cosmetics	05/18/2023	Appropriate tests, examinations; certificate of analysis
Global Vitality, Inc.	Food and Cosmetics	05/18/2023	Specifications met - verify; finished batch
Global Vitality, Inc.	Food and Cosmetics	05/18/2023	Specifications not met - reject, quality control
Global Vitality, Inc.	Food and Cosmetics	05/18/2023	Quality control - components, identity specifications
Global Vitality, Inc.	Food and Cosmetics	05/18/2023	Batch record - complete
Global Vitality, Inc.	Food and Cosmetics	05/18/2023	Examination, testing; appropriate
Global Vitality, Inc.	Food and Cosmetics	05/18/2023	Tests, examinations - scientifically valid
Herbally Yours, Inc.	Food and Cosmetics	03/22/2023	Quality control operations - in-process specifications
Herbally Yours, Inc.	Food and Cosmetics	03/22/2023	Retain reserve samples - 1 year, 2 years
International Marine Products, Inc.	Food and Cosmetics	03/14/2023	HACCP plan implementation
International Marine Products, Inc.	Food and Cosmetics	03/14/2023	Sanitation monitoring
Kedplasma, LLC	Biologics	01/26/2023	Donor medical history
La Sonorense, Inc.	Food and Cosmetics	05/26/2023	Sanitary operations - Plant sanitation
La Sonorense, Inc.	Food and Cosmetics	05/26/2023	Hazard analysis - Identification of hazard
La Sonorense, Inc.	Food and Cosmetics	05/26/2023	Allergen preventive controls - Appropriate (Adequate)
La Sonorense, Inc.	Food and Cosmetics	05/26/2023	Sanitation preventive controls - Appropriate (Adequate)
Med-Surgical Services, Inc.	Devices	07/18/2023	Management review - defined interval, sufficient frequency
Med-Surgical Services, Inc.	Devices	07/18/2023	Quality Audit/Reaudit - conducted
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
PETNET Solutions, Inc.	Drugs	09/08/2023	Orderly handling, prevention of mix-ups, prevention of contamination
PETNET Solutions, Inc.	Drugs	09/08/2023	Equipment procedures
PETNET Solutions, Inc.	Drugs	09/08/2023	Non-Conforming Product Investigation Incomplete
Promedtek, Inc.	Devices	03/22/2023	Lack of or inadequate final acceptance procedures
Promedtek, Inc.	Devices	03/22/2023	Records of complaint investigation
RCS Management Corporation	Devices	06/29/2023	Label to bear a unique device identifier
RCS Management Corporation	Devices	06/29/2023	Lack of or inadequate procedures
Shamy Market & Bakery	Food and Cosmetics	03/02/2023	Develop FSVP
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
Sina Health, Inc.	Drugs	01/13/2023	Calibration/Inspection/Checking not done
Sina Health, Inc.	Drugs	01/13/2023	Approval and review of procedures
Sina Health, Inc.	Drugs	01/13/2023	Examination of issued labels
Sina Health, Inc.	Drugs	01/13/2023	Review of representative number of batches
Soli Organic, Inc.	Food and Cosmetics	07/10/2023	Personnel
Surgenex, LLC	Biologics	03/29/2023	In-process HCT/Ps-control
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.
The Grateful Bread, Inc.	Food and Cosmetics	07/10/2023	Hazard analysis - Identification of hazard
The Grateful Bread, Inc.	Food and Cosmetics	07/10/2023	PCQI training records
The Grateful Bread, Inc.	Food and Cosmetics	07/10/2023	Supply-chain program - Establish
Venezia Bakery, Inc.	Food and Cosmetics	09/12/2023	Food safety plan
Venezia Bakery, Inc.	Food and Cosmetics	09/12/2023	PCQI training records
Western Milling, LLC	Veterinary	03/10/2023	Drug Components
Western Milling, LLC	Veterinary	03/10/2023	Pest Control
Western Milling, LLC	Veterinary	03/10/2023	Hazard Analysis
Western Milling, LLC	Veterinary	03/10/2023	Preventive Controls
World Class Distribution, Inc.	Food and Cosmetics	05/25/2023	HACCP plan implementation
World Class Distribution, Inc.	Food and Cosmetics	05/25/2023	No HACCP plan
World Class Distribution, Inc.	Food and Cosmetics	05/25/2023	Signed and dated
World Class Distribution, Inc.	Food and Cosmetics	05/25/2023	HACCP training or qualification