NE Bergen News

There were two companies in cities associated with Bergen County that received FDA citations as a result of two inspections conducted in the county over the third quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 33.3% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• You did not establish and maintain procedures for testing, screening and determining the eligibility of HCT/P donors.
• The summary of records for HCT/Ps did not contain a listing and an interpretation of results of all communicable disease tests performed.
• Donors were not screened by a review of relevant medical records for risk factors of communicable disease agents and diseases.

Both companies cited were involved in either Biologics or Drugs 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
Micra Biotechnologies, Inc.	Drugs	08/02/2024	Procedures not in writing, fully followed
Micra Biotechnologies, Inc.	Drugs	08/02/2024	GMP Training Frequency
Micra Biotechnologies, Inc.	Drugs	08/02/2024	Control / Lab Operations Area
Micra Biotechnologies, Inc.	Drugs	08/02/2024	Following/documenting laboratory controls
Micra Biotechnologies, Inc.	Drugs	08/02/2024	Scientifically sound laboratory controls
North Hudson IVF Center for Fertility & Gynecology, P.C.	Biologics	07/02/2024	Testing, screening, donor eligibility procedures
North Hudson IVF Center for Fertility & Gynecology, P.C.	Biologics	07/02/2024	Listing and interpretation of CD tests performed
North Hudson IVF Center for Fertility & Gynecology, P.C.	Biologics	07/02/2024	Risk factors, clinical evidence