Portland Maine News

There were three companies in cities associated with Cumberland 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 50% increase over the number of companies cited in the previous year.

The citations in the county include:

• You did not prepare and follow a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
• You did not prepare a batch production record every time you manufactured a batch of dietary supplement.
• Your batch production records did not include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained.

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

Of the companies cited, one should take a voluntary action to correct its managing operations (33.3%).

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
Global Biotechnologies, Inc.	Food and Cosmetics	04/13/2023	Master manufacturing record - each batch
Global Biotechnologies, Inc.	Food and Cosmetics	04/13/2023	Batch record - every batch
Global Biotechnologies, Inc.	Food and Cosmetics	04/13/2023	Batch record - date, time; maintenance
Klenda Seafood, Inc.	Food and Cosmetics	05/17/2023	Critical limits
Klenda Seafood, Inc.	Food and Cosmetics	05/17/2023	Records system
Klenda Seafood, Inc.	Food and Cosmetics	05/17/2023	Records values/observations
Northeast Air	Food and Cosmetics	02/09/2023	Record retention