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Rochester Reporter

Tuesday, December 24, 2024

How many companies in cities in Monroe County received FDA inspections in 2023?

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

There were 22 companies in cities associated with Monroe County, New York, that received 22 FDA inspections in 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 26.7% decrease from the number of companies inspected in the previous year, when 30 companies were inspected through 30 inspections.

Most of the companies inspected were involved in the Food/Cosmetics sector. The second most common type of company inspected in the time period worked in the Devices sector.

There were 19 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (86.4%). Three should take voluntary action to correct the organization's management operations (13.6%).

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.

Companies Located in Cities Within Monroe County and Their Inspection Results
Company NameArea of BusinessInspection DateResult
Alliance Precision Plastics CorporationDevices12/20/2023No Action Indicated (NAI)
BioTel Research, LLCDrugs04/26/2023No Action Indicated (NAI)
DJ Acquisition FTT, LLCDevices10/12/2023Voluntary Action Indicated (VAI)
Exxelia MicropenDevices11/14/2023No Action Indicated (NAI)
First Source, Inc.Devices09/19/2023Voluntary Action Indicated (VAI)
Fuego Coffee Roasters, LLCFood/Cosmetics08/09/2023No Action Indicated (NAI)
LiDestri Foods, Inc.Food/Cosmetics11/30/2023No Action Indicated (NAI)
McKesson Medical-SurgicalFood/Cosmetics07/25/2023No Action Indicated (NAI)
Medline Industries, LPFood/Cosmetics07/13/2023No Action Indicated (NAI)
Musculoskeletal Transplant FoundationBiologics05/24/2023No Action Indicated (NAI)
Napoli Specialty Concepts, Inc.Food/Cosmetics08/08/2023No Action Indicated (NAI)
Nortera Foods USAFood/Cosmetics09/25/2023No Action Indicated (NAI)
Paneffort, LLCDevices12/05/2023No Action Indicated (NAI)
Pennant Ingredients, Inc.Food/Cosmetics06/01/2023No Action Indicated (NAI)
Pennant Ingredients, Inc.Veterinary06/01/2023No Action Indicated (NAI)
Rochester Regional Health Fertility CareBiologics04/19/2023No Action Indicated (NAI)
Roechling Medical Rochester, L. P.Devices10/27/2023No Action Indicated (NAI)
Sight Society of NENY Lions Eye Bank of Rochester, Inc.Biologics05/03/2023No Action Indicated (NAI)
Ti-Ba Enterprises, Inc.Devices02/10/2023No Action Indicated (NAI)
Turbett Surgical, Inc.Devices06/26/2023Voluntary Action Indicated (VAI)
University of Rochester - Strong Memorial HospitalBiologics09/13/2023No Action Indicated (NAI)
Wegmans Food Markets, Inc.Food/Cosmetics05/04/2023No Action Indicated (NAI)
Wegmans Food Markets, Inc.Food/Cosmetics01/30/2023No Action Indicated (NAI)

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