Ames Today

There was one company in a city associated with Story County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous year.

The citations in the county include:

• Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
• Representative samples are not taken of each shipment of each lot of components for testing or examination.

The company cited was involved in the Drugs and Veterinary sectors.

The company cited had to take regulatory and/or administrative actions.

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
Continental Manufacturing Chemist	Drugs	05/10/2023	Written procedures not established/followed
Continental Manufacturing Chemist	Drugs	05/10/2023	Computer control of master formula records
Continental Manufacturing Chemist	Drugs	05/10/2023	Representative Samples
Continental Manufacturing Chemist	Drugs	05/10/2023	Reports of Analysis (Components)
Continental Manufacturing Chemist	Veterinary	05/10/2023	Written procedures not established/followed
Continental Manufacturing Chemist	Veterinary	05/10/2023	Computer control of master formula records
Continental Manufacturing Chemist	Veterinary	05/10/2023	Representative Samples
Continental Manufacturing Chemist	Veterinary	05/10/2023	Reports of Analysis (Components)