North Orlando News

There were 14 companies in cities associated with Orange 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 17.6% decrease from the number of companies cited in the previous year.

Of the 38 citations issued, the most common citation was 'You did not develop an FSVP'.

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 either Devices or Drugs sectors.

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
Acorn Stairlifts - Kingspointe Warehouse	Devices	05/12/2023	Lack of or inadequate complaint procedures
Banji Awosika, M.D.	Drugs	01/27/2023	FD-1572, protocol compliance
CEMI International, Inc.	Food and Cosmetics	11/03/2023	Component - verify identity, dietary ingredient
CEMI International, Inc.	Food and Cosmetics	11/03/2023	Specifications not met - reject, quality control
CEMI International, Inc.	Food and Cosmetics	11/03/2023	Written procedures - components
Crossing Jordan International, Inc.	Food and Cosmetics	06/29/2023	Quality control - quality, dietary supplement
Crossing Jordan International, Inc.	Food and Cosmetics	06/29/2023	Reserve sample - collect, hold
Crossing Jordan International, Inc.	Food and Cosmetics	06/29/2023	Written procedures - holding
EL Chilar-HF, LLC	Food and Cosmetics	09/18/2023	Sanitary operations - Plant sanitation
EL Chilar-HF, LLC	Food and Cosmetics	09/18/2023	Sanitation of non-food-contact surfaces - Manner and frequency
EL Chilar-HF, LLC	Food and Cosmetics	09/18/2023	Equipment and utensils - Design and maintenance
EL Chilar-HF, LLC	Food and Cosmetics	09/18/2023	Manufacturing, processing, packing, holding - Controls
EL Chilar-HF, LLC	Food and Cosmetics	09/18/2023	Storage and Distribution
EL Chilar-HF, LLC	Food and Cosmetics	09/18/2023	HACCP plan implementation
EL Chilar-HF, LLC	Food and Cosmetics	09/18/2023	Critical control points
EL Chilar-HF, LLC	Food and Cosmetics	09/18/2023	Signed and dated
EL Chilar-HF, LLC	Food and Cosmetics	09/18/2023	Sanitation monitoring
Farm and Pet Outlet, LLC	Veterinary	08/10/2023	Develop FSVP
Global Imports Florida	Food and Cosmetics	06/07/2023	Hold - mix-up, contamination, deterioration
Global Imports Florida	Food and Cosmetics	06/07/2023	Retain reserve samples - 1 year, 2 years
Global Imports Florida	Food and Cosmetics	06/07/2023	Returned dietary supplement - material review, disposition
H & H Products Company	Food and Cosmetics	03/10/2023	Process filing
H & H Products Company	Food and Cosmetics	03/10/2023	Personnel
H & H Products Company	Food and Cosmetics	03/10/2023	Sanitary operations - Plant sanitation
H & H Products Company	Food and Cosmetics	03/10/2023	Sanitation monitoring
H & H Products Company	Food and Cosmetics	03/10/2023	HACCP plan - critical limits not listed or not adequate
H & H Products Company	Food and Cosmetics	03/10/2023	Process controls - HACCP plan - 5 log reduction
Hawkers	Food and Cosmetics	05/01/2023	Verification procedures - adequacy
Hawkers	Food and Cosmetics	05/01/2023	Verification procedures - none/frequency
Hawkers	Food and Cosmetics	05/01/2023	Signed and dated
Hawkers	Food and Cosmetics	05/01/2023	HACCP training or qualification
Hawkers	Food and Cosmetics	05/01/2023	Sanitation Records
Hevener Sales, Inc.	Food and Cosmetics	10/24/2023	Develop FSVP
Kwabena Ayesu, M.D.	Drugs	01/27/2023	FD-1572, protocol compliance
Kwabena Ayesu, M.D.	Drugs	01/27/2023	Unanticipated problems
Lotia Trust, Inc.	Food and Cosmetics	04/04/2023	Develop FSVP
Optimotion Implants, LLC	Devices	10/20/2023	Product rework adverse effects {see also 820.184}
Prodalim USA, Inc.	Food and Cosmetics	01/12/2023	Sanitation monitoring