OKC Standard

There were 10 companies in cities associated with Cleveland County that received FDA citations as a result of 11 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.

Of the 26 citations issued, the most common citation was 'You did not ensure that the tests or examinations that you used to determine whether the specifications are met are appropriate, scientifically valid methods'.

Most of the companies cited were involved in the Food and Cosmetics 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
Ameri-Kal, LLC	Food and Cosmetics	09/12/2023	Component - verify identity, dietary ingredient
Ameri-Kal, LLC	Food and Cosmetics	09/12/2023	Quality control operations - finished batch, specifications
Ameri-Kal, LLC	Food and Cosmetics	09/12/2023	Corrective action plans
Ameri-Kal, LLC	Food and Cosmetics	09/12/2023	Tests, examinations - scientifically valid
BTI Filtration	Devices	05/11/2023	Purchasing controls, Lack of or inadequate procedures
BTI Filtration	Devices	05/11/2023	Lack of or inadequate receiving acceptance procedures
Immuno-Mycologics, Inc.	Devices	07/14/2023	Evaluation of suppliers, contractors, etc., requirements
Immuno-Mycologics, Inc.	Devices	07/14/2023	Lack of or inadequate process validation
Kathleen N. Moore, M.D.	Drugs	03/17/2023	FD-1572, protocol compliance
Quality Supplement Manufacturing, Inc.	Food and Cosmetics	10/18/2023	Quality control - reject; specification not met
Quality Supplement Manufacturing, Inc.	Food and Cosmetics	10/18/2023	Criteria for establishing specifications
Quality Supplement Manufacturing, Inc.	Food and Cosmetics	10/18/2023	Tests, examinations - scientifically valid
Quality Supplement Manufacturing, Inc.	Food and Cosmetics	05/04/2023	Personnel - education, training, experience
Quality Supplement Manufacturing, Inc.	Food and Cosmetics	05/04/2023	Specifications - identity, purity, strength, composition
Quality Supplement Manufacturing, Inc.	Food and Cosmetics	05/04/2023	Specifications not met - reject, quality control
Quality Supplement Manufacturing, Inc.	Food and Cosmetics	05/04/2023	Material review, disposition, follow-up; identification
Quality Supplement Manufacturing, Inc.	Food and Cosmetics	05/04/2023	Master manufacturing record - sampling, tests, examinations
Quality Supplement Manufacturing, Inc.	Food and Cosmetics	05/04/2023	Batch record - follow master
Quality Supplement Manufacturing, Inc.	Food and Cosmetics	05/04/2023	Batch record - manufacture
Quality Supplement Manufacturing, Inc.	Food and Cosmetics	05/04/2023	Batch record - reprocessing
Quality Supplement Manufacturing, Inc.	Food and Cosmetics	05/04/2023	Tests, examinations - scientifically valid
Route 66 Provisions, L.L.C.	Food and Cosmetics	09/19/2023	Pest control
Seeds N Snacks, LLC.	Food and Cosmetics	07/12/2023	Develop FSVP
Steven Sarkisian, M.D.	Drugs	08/04/2023	FD-1572, protocol compliance
TVT Sharetea, LLC	Food and Cosmetics	07/13/2023	Develop FSVP
US Foods	Food and Cosmetics	02/03/2023	Food safety hazards