Brevard Sun

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

This is a 600% increase over the number of companies cited in the previous year.

Of the 25 citations issued, the most common citation was 'You did not prepare a written master manufacturing record for each batch size of a dietary supplement that you manufactured'.

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, six should take voluntary actions to correct their managing operations (85.7%). Additionally, one company had to take regulatory and/or administrative actions (14.3%).

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
Botany Evolution, LLC	Food and Cosmetics	07/19/2023	Specifications - product received for packaging, labeling
Botany Evolution, LLC	Food and Cosmetics	07/19/2023	Written procedures - quality control operations
Botany Evolution, LLC	Food and Cosmetics	07/19/2023	Master manufacturing record - each batch
Botany Evolution, LLC	Food and Cosmetics	07/19/2023	Batch record - every batch
Botany Evolution, LLC	Food and Cosmetics	07/19/2023	Examination, testing; appropriate
Botany Evolution, LLC	Food and Cosmetics	07/19/2023	Batch-lot,control number packaged, labeled dietary supplemen
Ceba-Tek, Inc.	Food and Cosmetics	02/17/2023	Equipment - maintain, clean, sanitize
Ceba-Tek, Inc.	Food and Cosmetics	02/17/2023	Equipment - controls - QC
Ceba-Tek, Inc.	Food and Cosmetics	02/17/2023	Specifications - component identity
Ceba-Tek, Inc.	Food and Cosmetics	02/17/2023	Specifications-component purity, strength, composition
Ceba-Tek, Inc.	Food and Cosmetics	02/17/2023	Specifications - contamination limits
Ceba-Tek, Inc.	Food and Cosmetics	02/17/2023	Component - qualify supplier
Ceba-Tek, Inc.	Food and Cosmetics	02/17/2023	Master manufacturing record - each batch
Han Tang Import & Export, Inc.	Food and Cosmetics	10/11/2023	Written procedures - holding
Han Tang Import & Export, Inc.	Food and Cosmetics	10/11/2023	Written procedures - returned dietary supplement
LL Imports & Exports USA, LLC	Food and Cosmetics	07/13/2023	Develop FSVP
Viera Fertility Center	Biologics	02/03/2023	Risk factors, clinical evidence
Ward Photonics, LLC	Devices	01/19/2023	Lack of Written MDR Procedures
Ward Photonics, LLC	Devices	01/19/2023	Purchasing controls, Lack of or inadequate procedures
Ward Photonics, LLC	Devices	01/19/2023	Approval, inadequate purchasing data
Ward Photonics, LLC	Devices	01/19/2023	Lack of or inadequate procedures
Ward Photonics, LLC	Devices	01/19/2023	Lack of or inadequate complaint procedures
Wellness Without Limits, LLC	Devices	10/17/2023	Lack of Written MDR Procedures
Wellness Without Limits, LLC	Devices	10/17/2023	Lack of or inadequate procedures
Wellness Without Limits, LLC	Devices	10/17/2023	Lack of or inadequate complaint procedures