Rockland Reporter

There were three companies in cities associated with Rockland County that received FDA citations as a result of three inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 57.1% decrease from the number of companies cited in the previous year.

The citations in the county include:

• You did not establish product specifications for the identity, strength and composition of the finished dietary supplement.
• You did not keep the records required for your quality control operations as original records, true copies, or as electronic records.
• You did not clearly identify, hold, and control under a quarantine system for appropriate disposition a component, labels and product that you received for packaging or labeling as a dietary supplement that was rejected and unsuitable for use in manufacturing, packaging, or labeling operations.

All 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
American Biosciences, Inc.	Food and Cosmetics	08/07/2023	Specifications - identity, purity, strength, composition
American Biosciences, Inc.	Food and Cosmetics	08/07/2023	Records - QC operations: originals, copies, electronic
American Biosciences, Inc.	Food and Cosmetics	08/07/2023	Quarantine component, package, labels, rejected product
American Biosciences, Inc.	Food and Cosmetics	08/07/2023	Written procedures - labeling operations
BeeAlive, Inc.	Food and Cosmetics	01/18/2023	Quality control - finished batch, distribution
BeeAlive, Inc.	Food and Cosmetics	01/18/2023	Written procedures - product complaint; review, investigate
Best Choice Confectionary, Inc.	Food and Cosmetics	01/19/2023	Sanitary operations - Plant sanitation