North Baltimore Journal

There were two companies in cities associated with Baltimore County that received FDA citations as a result of two inspections conducted in the county over the fourth quarter of 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 quarter.

The citations in the county include:

• The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
• Procedures for training and identifying training needs have not been adequately established.
• The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.

Both companies cited were involved in either Devices or Biologics sectors.

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
Greater Baltimore Medical Center	Biologics	10/26/2023	Equipment observed, standardized, calibrated
Greater Baltimore Medical Center	Biologics	10/26/2023	SOPs for investigations, records
Shikani Medical, LLC	Devices	12/21/2023	Lack of or inadequate organizational structure
Shikani Medical, LLC	Devices	12/21/2023	Training - Lack of or inadequate procedures
Shikani Medical, LLC	Devices	12/21/2023	Design history file
Shikani Medical, LLC	Devices	12/21/2023	Evaluation and Selection, Suppliers, Contractors, etc.
Shikani Medical, LLC	Devices	12/21/2023	Lack of or inadequate receiving acceptance procedures
Shikani Medical, LLC	Devices	12/21/2023	Lack of or inadequate complaint procedures