South Palm Beach Today

There were 16 companies in cities associated with Palm Beach County that received FDA citations as a result of 16 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 5.9% decrease from the number of companies cited in the previous year.

Of the 51 citations issued, the most common citation was 'You did not develop an FSVP'.

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

Of the companies cited, 15 should take voluntary actions to correct their managing operations (93.8%). Additionally, one company had to take regulatory and/or administrative actions (6.3%).

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
Allied Pharmacy Products., Inc.	Devices	01/10/2023	Design transfer - Lack of or inadequate procedures
Allied Pharmacy Products., Inc.	Devices	01/10/2023	Documentation
Arcadlab, LLC	Devices	09/01/2023	Management review dates
Arcadlab, LLC	Devices	09/01/2023	Design control - no procedures
Arcadlab, LLC	Devices	09/01/2023	Lack of or inadequate DHR procedures
Bing Innovations, LLC	Devices	10/17/2023	Management representative
Bing Innovations, LLC	Devices	10/17/2023	Quality System Procedures
Bing Innovations, LLC	Devices	10/17/2023	Quality audits - Lack of or inadequate procedures
Bing Innovations, LLC	Devices	10/17/2023	Training - Lack of or inadequate procedures
Bing Innovations, LLC	Devices	10/17/2023	Purchasing controls, Lack of or inadequate procedures
Bing Innovations, LLC	Devices	10/17/2023	Lack of or inadequate procedures
Bing Innovations, LLC	Devices	10/17/2023	Lack of or inadequate complaint procedures
Biomedical Regenerative GF, LLC	Devices	05/30/2023	Lack of Written MDR Procedures
Biomedical Regenerative GF, LLC	Devices	05/30/2023	Management representative
Biomedical Regenerative GF, LLC	Devices	05/30/2023	Design control - no procedures
Biomedical Regenerative GF, LLC	Devices	05/30/2023	Design Validation - Risk analysis not performed/inadequate
Biomedical Regenerative GF, LLC	Devices	05/30/2023	Lack of procedures, or not maintained
Biomedical Regenerative GF, LLC	Devices	05/30/2023	DMR - not or inadequately maintained
Boca Fertility	Biologics	11/01/2023	Risk factors, clinical evidence
Classical Insights, LLC	Food and Cosmetics	01/24/2023	Production, process controls - packaged, labeled
Classical Insights, LLC	Food and Cosmetics	01/24/2023	Written procedures - holding; distributing
Classical Insights, LLC	Food and Cosmetics	01/24/2023	Records - returned dietary supplement: written procedures
Classical Insights, LLC	Food and Cosmetics	01/24/2023	Sanitation of food-contact surfaces - Frequency
E5 Pharma, LLC	Drugs	02/17/2023	Failure to develop written procedures
E5 Pharma, LLC	Drugs	02/17/2023	Failure to submit ADE report
E5 Pharma, LLC	Drugs	02/17/2023	Failure to develop written procedures
E5 Pharma, LLC	Drugs	02/17/2023	Incomplete periodic safety report
Faico Medical, LLC	Devices	05/02/2023	Rationale documented for no investigation
Foods USA, Inc.	Food and Cosmetics	10/06/2023	Develop FSVP
Fresh Start Produce Sales, Inc.	Food and Cosmetics	10/16/2023	Develop FSVP
Pangea Growers Group, LLC	Food and Cosmetics	11/14/2023	Develop FSVP
Products By O2, Inc.	Drugs	10/23/2023	Procedures not in writing, fully followed
Products By O2, Inc.	Drugs	10/23/2023	Washing and toilet facilities are deficient
Products By O2, Inc.	Drugs	10/23/2023	Equipment Design, Size and Location
Products By O2, Inc.	Drugs	10/23/2023	Written procedures not established/followed
Products By O2, Inc.	Drugs	10/23/2023	Component identification test
Products By O2, Inc.	Drugs	10/23/2023	Approval and review of procedures
Products By O2, Inc.	Drugs	10/23/2023	Changes to Procedures Not Reviewed, Approved
Products By O2, Inc.	Drugs	10/23/2023	Control procedures to monitor and validate performance
Products By O2, Inc.	Drugs	10/23/2023	Label storage access limited to authorized personnel
Products By O2, Inc.	Drugs	10/23/2023	Scientifically sound laboratory controls
Products By O2, Inc.	Drugs	10/23/2023	Reserve samples identified, representative, stored
Redcon 1	Food and Cosmetics	06/26/2023	Written procedures - quality control operations
Stingray Surgical Products, LLC	Devices	02/09/2023	Design changes - Lack of or Inadequate Procedures
Stingray Surgical Products, LLC	Devices	02/09/2023	Lack of or inadequate procedures
The Pyure Company, Inc.	Devices	01/20/2023	Design input - documentation
The Pyure Company, Inc.	Devices	01/20/2023	Design transfer - Lack of or inadequate procedures
The Pyure Company, Inc.	Devices	01/20/2023	Evaluation and Selection, Suppliers, Contractors, etc.
VapoCoolShot, Inc.	Devices	10/26/2023	Management review dates
VapoCoolShot, Inc.	Devices	10/26/2023	Quality Audits - defined intervals
VapoCoolShot, Inc.	Devices	10/26/2023	Training records