Treasure Coast Sun

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

This is unchanged from the number of companies cited in the previous year.

The citations in the county include:

• Schedules for the adjustment, cleaning, and other maintenance of equipment have not been adequately established.
• Corrective and preventive action activities and/or results have not been adequately documented.
• Records of complaint investigations do not include required information.

Most of the companies cited were involved in the Devices sector.

All of the companies cited should take voluntary actions to correct their managing operations.

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
Aphrodite's Apothecary, LLC.	Food and Cosmetics	07/25/2023	Procedures - calibrating automated, mechanical equip
Aphrodite's Apothecary, LLC.	Food and Cosmetics	07/25/2023	Specifications - identity, purity, strength, composition
Aphrodite's Apothecary, LLC.	Food and Cosmetics	07/25/2023	Records - quality control operations; responsibilities
Aphrodite's Apothecary, LLC.	Food and Cosmetics	07/25/2023	Written procedures - rejected components, packaging, labels
Aphrodite's Apothecary, LLC.	Food and Cosmetics	07/25/2023	Packaging description, representative label
Aphrodite's Apothecary, LLC.	Food and Cosmetics	07/25/2023	Batch record - date, time; maintenance
Aphrodite's Apothecary, LLC.	Food and Cosmetics	07/25/2023	Batch record - packaging, labeling
Aphrodite's Apothecary, LLC.	Food and Cosmetics	07/25/2023	Batch record - quality control review; production
Aphrodite's Apothecary, LLC.	Food and Cosmetics	07/25/2023	Batch record - performance
Aphrodite's Apothecary, LLC.	Food and Cosmetics	07/25/2023	Records - packaging, labeling operations
Aphrodite's Apothecary, LLC.	Food and Cosmetics	07/25/2023	Written procedures - holding; distributing
Aphrodite's Apothecary, LLC.	Food and Cosmetics	07/25/2023	Records - returned dietary supplement: written procedures
Aphrodite's Apothecary, LLC.	Food and Cosmetics	07/25/2023	Written procedures - product complaint; review, investigate
Avotec, Inc.	Devices	01/27/2023	Quality Audit/Reaudit - conducted
Avotec, Inc.	Devices	01/27/2023	Training - Lack of or inadequate procedures
Avotec, Inc.	Devices	01/27/2023	Rationale documented for no investigation
Awareness Technology, Inc.	Devices	06/12/2023	Maintenance schedule, Lack of or inadequate schedule
Awareness Technology, Inc.	Devices	06/12/2023	Documentation
Awareness Technology, Inc.	Devices	06/12/2023	Records of complaint investigation