Miami Courant

There were two companies in a city associated with Miami-Dade County that received FDA citations as a result of two inspections conducted in the county in February, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous month.

The citations in the county include:

• The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
• Document control procedures have not been adequately established.
• Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.

Both 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
Advanced Instrumentations, Inc.	Devices	02/26/2024	Design history file
Advanced Instrumentations, Inc.	Devices	02/26/2024	Procedures not adequately established or maintained
Advanced Instrumentations, Inc.	Devices	02/26/2024	Purchasing controls, Lack of or inadequate procedures
Medipharm Laboratories, Inc.	Drugs	02/23/2024	Procedures not in writing, fully followed
Medipharm Laboratories, Inc.	Drugs	02/23/2024	Training--operations, GMPs, written procedures