Pinellas Times

There were 14 companies in cities associated with Pinellas County that received FDA citations as a result of 14 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 55.6% increase over the number of companies cited in the previous year.

Of the 71 citations issued, the most common citations include:

• Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
• Procedures for corrective and preventive action have not been adequately established.
• Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.

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 either Food and Cosmetics or Drugs sectors.

Of the companies cited, 13 should take voluntary actions to correct their managing operations (92.9%). Additionally, one company had to take regulatory and/or administrative actions (7.1%).

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
BL Bio Lab	Food and Cosmetics	06/30/2023	Quality control - required operations product complaints
BL Bio Lab	Food and Cosmetics	06/30/2023	Manufacturing operations - written procedures
BL Bio Lab	Food and Cosmetics	06/30/2023	Metal, foreign material
Body, LLC	Food and Cosmetics	05/18/2023	Records - equipment; calibrations, inspections, checks
Body, LLC	Food and Cosmetics	05/18/2023	Documentation - quality control, review, approve supplier
Body, LLC	Food and Cosmetics	05/18/2023	Batch record - complete
Body, LLC	Food and Cosmetics	05/18/2023	Batch record - identifier; labels
Catalent Pharma Solutions, LLC	Food and Cosmetics	07/21/2023	Equipment - maintain, clean, sanitize
Catalent Pharma Solutions, LLC	Food and Cosmetics	07/21/2023	Specifications - component identity
Catalent Pharma Solutions, LLC	Food and Cosmetics	07/21/2023	Specifications-component purity, strength, composition
Catalent Pharma Solutions, LLC	Food and Cosmetics	07/21/2023	Specifications - contamination limits
Catalent Pharma Solutions, LLC	Food and Cosmetics	07/21/2023	Specifications - labels, packaging
Catalent Pharma Solutions, LLC	Food and Cosmetics	07/21/2023	Specifications - identity, purity, strength, composition
Catalent Pharma Solutions, LLC	Food and Cosmetics	07/21/2023	Master manufacturing record - unique formulation
Catalent Pharma Solutions, LLC	Food and Cosmetics	07/21/2023	Batch record - complete
Eagle Labs, Inc.	Drugs	12/06/2023	Written procedures not established/followed
Eagle Labs, Inc.	Drugs	12/06/2023	SOPs not followed / documented
Florida Fertility Institute, P. A.	Biologics	02/02/2023	Procedures for all other requirements
Florida Fertility Institute, P. A.	Biologics	02/02/2023	Testing, screening, donor eligibility procedures
Florida Fertility Institute, P. A.	Biologics	02/02/2023	Determination based on screening and testing
Florida Fertility Institute, P. A.	Biologics	02/02/2023	Responsible person to determine, document
Florida Fertility Institute, P. A.	Biologics	02/02/2023	Name and personal info on accompanying records
Florida Fertility Institute, P. A.	Biologics	02/02/2023	Labeled re: biohazard, risks, test results
Florida Fertility Institute, P. A.	Biologics	02/02/2023	Risk factors, clinical evidence
Florida Fertility Institute, P. A.	Biologics	02/02/2023	Eligibility not required--warning labels
Infinium Medical, Inc.	Devices	11/08/2023	Individual Report of Malfunction
Infinium Medical, Inc.	Devices	11/08/2023	Service reports/MDRs/complaints
J&T Health and Wellness, LLC	Devices	10/18/2023	Design Validation - Risk analysis not performed/inadequate
J&T Health and Wellness, LLC	Devices	10/18/2023	Design changes - Lack of or Inadequate Procedures
J&T Health and Wellness, LLC	Devices	10/18/2023	Documentation of software validation
J&T Health and Wellness, LLC	Devices	10/18/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
J&T Health and Wellness, LLC	Devices	10/18/2023	Documentation
J&T Health and Wellness, LLC	Devices	10/18/2023	Nonconforming product, Lack of or inadequate procedures
J&T Health and Wellness, LLC	Devices	10/18/2023	Lack of or inadequate procedures
J&T Health and Wellness, LLC	Devices	10/18/2023	Lack of or inadequate complaint procedures
Jennifer W. Leiding, M.D.	Biologics	09/08/2023	Informed consent
Jennifer W. Leiding, M.D.	Biologics	09/08/2023	Case history records- inadequate or inadequate
Jennifer W. Leiding, M.D.	Biologics	09/08/2023	Safety Reports - Non-Serious Events
McPherson Enterprises, Inc.	Devices	09/06/2023	Design Validation - Risk analysis not performed/inadequate
McPherson Enterprises, Inc.	Devices	09/06/2023	Design validation acceptance criteria
McPherson Enterprises, Inc.	Devices	09/06/2023	Purchasing controls, Lack of or inadequate procedures
McPherson Enterprises, Inc.	Devices	09/06/2023	Environmental control Lack of or inadequate procedures
Pharmetric Laboratory, LLC	Drugs	11/06/2023	Procedures not in writing, fully followed
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Procedures not in writing, fully followed
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Buildings of Suitable Size, Construction, Location
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Environmental Monitoring System
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Cleaning / Sanitizing / Maintenance
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Written procedures not established/followed
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Component identification test
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Protection from external factors
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Validation lacking for sterile drug products
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Samples (various types) representative, identified properly
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Results not used for expiration dates, storage cond.
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Retention time of reserve samples, in general
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Record maintenance 1 year (except exempt OTC)
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Identification of each component or in-process material
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Investigations of discrepancies, failures
Regenerative Processing Plant, LLC	Drugs	06/30/2023	Complete Test Data
Sun Dental Laboratories, LLC	Devices	09/20/2023	Lack of Written MDR Procedures
Sun Dental Laboratories, LLC	Devices	09/20/2023	Supplier notification of changes
Sun Dental Laboratories, LLC	Devices	09/20/2023	Labeling inspection - UDI
Suncoast Dental, Inc.	Devices	05/04/2023	Design verification - output does not meet input requirement
Suncoast Dental, Inc.	Devices	05/04/2023	Design Validation - Risk analysis not performed/inadequate
Suncoast Dental, Inc.	Devices	05/04/2023	Lack of or inadequate procedures - Acceptance activities
Suncoast Dental, Inc.	Devices	05/04/2023	Documentation
Ultra Clean Systems, Inc.	Devices	08/11/2023	Lack of System for Timely Submission of Reports
Ultra Clean Systems, Inc.	Devices	08/11/2023	Design control - no procedures
Ultra Clean Systems, Inc.	Devices	08/11/2023	Purchasing controls, Lack of or inadequate procedures
Ultra Clean Systems, Inc.	Devices	08/11/2023	Software validation for automated processes
Ultra Clean Systems, Inc.	Devices	08/11/2023	Lack of or inadequate procedures
Ultra Clean Systems, Inc.	Devices	08/11/2023	Lack of or inadequate complaint procedures