Central Virginia Times

There were two companies in the City of Charlottesville that received FDA citations as a result of two inspections conducted in the city throughout 2023, 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 year.

Of the 58 citations issued, the most common citations include:

• You did not establish written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement.
• You did not establish an identity specification for each component.
• You did not establish component specifications for purity, strength and composition.

Most of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, two should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (50%).

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
Afton Scientific, LLC	Food and Cosmetics	10/06/2023	Sanitation preventive controls - Appropriate (Adequate)
Afton Scientific, LLC	Food and Cosmetics	10/06/2023	Supply-chain program - Assurance (Adequate)
Afton Scientific, LLC	Food and Cosmetics	10/06/2023	Procedures not in writing, fully followed
Afton Scientific, LLC	Food and Cosmetics	10/06/2023	Training , Education , Experience overall
Afton Scientific, LLC	Food and Cosmetics	10/06/2023	Absence of Written Procedures
Afton Scientific, LLC	Food and Cosmetics	10/06/2023	Control procedures to monitor and validate performance
Afton Scientific, LLC	Food and Cosmetics	10/06/2023	Storage under appropriate conditions
Afton Scientific, LLC	Food and Cosmetics	10/06/2023	Drug products - samples representative, identified properly
Afton Scientific, LLC	Biologics	10/06/2023	Sanitation preventive controls - Appropriate (Adequate)
Afton Scientific, LLC	Biologics	10/06/2023	Supply-chain program - Assurance (Adequate)
Afton Scientific, LLC	Biologics	10/06/2023	Procedures not in writing, fully followed
Afton Scientific, LLC	Biologics	10/06/2023	Training , Education , Experience overall
Afton Scientific, LLC	Biologics	10/06/2023	Absence of Written Procedures
Afton Scientific, LLC	Biologics	10/06/2023	Control procedures to monitor and validate performance
Afton Scientific, LLC	Biologics	10/06/2023	Storage under appropriate conditions
Afton Scientific, LLC	Biologics	10/06/2023	Drug products - samples representative, identified properly
Biomic Sciences, LLC	Drugs	08/31/2023	Procedures - calibrating instruments
Biomic Sciences, LLC	Drugs	08/31/2023	Specifications - component identity
Biomic Sciences, LLC	Drugs	08/31/2023	Specifications-component purity, strength, composition
Biomic Sciences, LLC	Drugs	08/31/2023	Specifications - contamination limits
Biomic Sciences, LLC	Drugs	08/31/2023	Specifications - identity, purity, strength, composition
Biomic Sciences, LLC	Drugs	08/31/2023	Specifications met - verify; finished batch
Biomic Sciences, LLC	Drugs	08/31/2023	Components - quarantine
Biomic Sciences, LLC	Drugs	08/31/2023	Master manufacturing record - each batch
Biomic Sciences, LLC	Drugs	08/31/2023	Batch record - complete
Biomic Sciences, LLC	Drugs	08/31/2023	Scheduled processes not established
Biomic Sciences, LLC	Drugs	08/31/2023	Procedures for non-sterile drug products
Biomic Sciences, LLC	Drugs	08/31/2023	Microbiological testing
Biomic Sciences, LLC	Drugs	08/31/2023	Quality control - processes, specifications, written procedures
Biomic Sciences, LLC	Drugs	08/31/2023	Quality control operations - master manufacturing record, modifications
Biomic Sciences, LLC	Food and Cosmetics	08/31/2023	Procedures - calibrating instruments
Biomic Sciences, LLC	Food and Cosmetics	08/31/2023	Specifications - component identity
Biomic Sciences, LLC	Food and Cosmetics	08/31/2023	Specifications-component purity, strength, composition
Biomic Sciences, LLC	Food and Cosmetics	08/31/2023	Specifications - contamination limits
Biomic Sciences, LLC	Food and Cosmetics	08/31/2023	Specifications - identity, purity, strength, composition
Biomic Sciences, LLC	Food and Cosmetics	08/31/2023	Specifications met - verify; finished batch
Biomic Sciences, LLC	Food and Cosmetics	08/31/2023	Components - quarantine
Biomic Sciences, LLC	Food and Cosmetics	08/31/2023	Master manufacturing record - each batch
Biomic Sciences, LLC	Food and Cosmetics	08/31/2023	Batch record - complete
Biomic Sciences, LLC	Food and Cosmetics	08/31/2023	Scheduled processes not established
Biomic Sciences, LLC	Food and Cosmetics	08/31/2023	Procedures for non-sterile drug products
Biomic Sciences, LLC	Food and Cosmetics	08/31/2023	Microbiological testing
Biomic Sciences, LLC	Food and Cosmetics	08/31/2023	Quality control - processes, specifications, written procedures
Biomic Sciences, LLC	Food and Cosmetics	08/31/2023	Quality control operations - master manufacturing record, modifications
Biomic Sciences, LLC	Veterinary	08/31/2023	Procedures - calibrating instruments
Biomic Sciences, LLC	Veterinary	08/31/2023	Specifications - component identity
Biomic Sciences, LLC	Veterinary	08/31/2023	Specifications-component purity, strength, composition
Biomic Sciences, LLC	Veterinary	08/31/2023	Specifications - contamination limits
Biomic Sciences, LLC	Veterinary	08/31/2023	Specifications - identity, purity, strength, composition
Biomic Sciences, LLC	Veterinary	08/31/2023	Specifications met - verify; finished batch
Biomic Sciences, LLC	Veterinary	08/31/2023	Components - quarantine
Biomic Sciences, LLC	Veterinary	08/31/2023	Master manufacturing record - each batch
Biomic Sciences, LLC	Veterinary	08/31/2023	Batch record - complete
Biomic Sciences, LLC	Veterinary	08/31/2023	Scheduled processes not established
Biomic Sciences, LLC	Veterinary	08/31/2023	Procedures for non-sterile drug products
Biomic Sciences, LLC	Veterinary	08/31/2023	Microbiological testing
Biomic Sciences, LLC	Veterinary	08/31/2023	Quality control - processes, specifications, written procedures
Biomic Sciences, LLC	Veterinary	08/31/2023	Quality control operations - master manufacturing record, modifications