Rockland Reporter

There were two companies in a city associated with Rockland County that received FDA citations as a result of two inspections conducted in the county over the fourth quarter of 2024, 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 quarter.

The citations in the county include:

• 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.
• Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

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
Intercos America, Inc.	Drugs	10/09/2024	Computer control of master formula records
Vitane Pharmaceutical, Inc.	Drugs	10/23/2024	Cleaning / Sanitizing / Maintenance
Vitane Pharmaceutical, Inc.	Drugs	10/23/2024	Reports of Analysis (Components)
Vitane Pharmaceutical, Inc.	Drugs	10/23/2024	Absence of Written Procedures
Vitane Pharmaceutical, Inc.	Drugs	10/23/2024	Storage under appropriate conditions
Vitane Pharmaceutical, Inc.	Drugs	10/23/2024	Records reviewed annually