How many companies in cities across Oakland County received FDA citations in 2024?

How many companies in cities across Oakland County received FDA citations in 2024?
Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) — Official website
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There were 10 companies in cities associated with Oakland County that received FDA citations as a result of 10 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 42.9% increase over the number of companies cited in the previous year.

Of the 49 citations issued, the most common citation was ‘The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed’.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the Drugs sector.

Of the companies cited, eight should take voluntary actions to correct their managing operations (80%). Additionally, two companies had to take regulatory and/or administrative actions (20%).

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.

According to its website, 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.

Companies Located Within Oakland County Cities and the Citations They Received in 2024
Company Name Area of Business Inspection Date Issue Cited
BB Global Supplies Chain, LLC. Food and Cosmetics 04/05/2024 Develop FSVP
Blue Line Food Service Distribution Food and Cosmetics 12/06/2024 Allergen preventive controls – Appropriate (Adequate)
Capital Sales Company Ferndale, Mi Food and Cosmetics 02/14/2024 Develop FSVP
Excel Medical Products, Inc. Devices 04/01/2024 Statistical techniques – Lack of or inadequate procedures
Future Pak, Ltd. Drugs 10/15/2024 Procedures not in writing, fully followed
Future Pak, Ltd. Drugs 10/15/2024 Written procedures not established/followed
Future Pak, Ltd. Drugs 10/15/2024 SOPs not followed / documented
Future Pak, Ltd. Drugs 10/15/2024 Written in-process control procedures
Future Pak, Ltd. Drugs 10/15/2024 Following/documenting laboratory controls
Future Pak, Ltd. Drugs 10/15/2024 Investigations of discrepancies, failures
Future Pak, Ltd. Veterinary 10/15/2024 Procedures not in writing, fully followed
Future Pak, Ltd. Veterinary 10/15/2024 Written procedures not established/followed
Future Pak, Ltd. Veterinary 10/15/2024 SOPs not followed / documented
Future Pak, Ltd. Veterinary 10/15/2024 Written in-process control procedures
Future Pak, Ltd. Veterinary 10/15/2024 Following/documenting laboratory controls
Future Pak, Ltd. Veterinary 10/15/2024 Investigations of discrepancies, failures
Knickerbocker 365, Inc. Food and Cosmetics 05/31/2024 Food safety plan – Preparation
Knickerbocker 365, Inc. Food and Cosmetics 05/31/2024 Hazard analysis – Identification of hazard
Knickerbocker 365, Inc. Food and Cosmetics 05/31/2024 Allergen preventive controls – Identify (Written)
Knickerbocker 365, Inc. Food and Cosmetics 05/31/2024 Process preventive controls – Identify (Written)
Knickerbocker 365, Inc. Food and Cosmetics 05/31/2024 Allergen preventive controls – Appropriate (Adequate)
LXR Biotech Food and Cosmetics 02/16/2024 Equipment – automated – suitability
LXR Biotech Food and Cosmetics 02/16/2024 Specifications – component identity
LXR Biotech Food and Cosmetics 02/16/2024 Specifications-component purity, strength, composition
LXR Biotech Food and Cosmetics 02/16/2024 Specifications – identity, purity, strength, composition
LXR Biotech Food and Cosmetics 02/16/2024 Component – verify identity, dietary ingredient
LXR Biotech Food and Cosmetics 02/16/2024 Component – confirm identity; specifications met
LXR Biotech Food and Cosmetics 02/16/2024 Quality control – reject; specification not met
LXR Biotech Food and Cosmetics 02/16/2024 Master manufacturing record theoretical and expected yield
LXR Biotech Food and Cosmetics 02/16/2024 Master manufacturing record – sampling, tests, examinations
LXR Biotech Food and Cosmetics 02/16/2024 Master manufacturing record – specific actions; quality
LXR Biotech Food and Cosmetics 02/16/2024 Batch record – date, time; maintenance
LXR Biotech Food and Cosmetics 02/16/2024 Batch record – identifier; labels
LXR Biotech Food and Cosmetics 02/16/2024 Standard reference materials; criteria for selecting
LXR Biotech Food and Cosmetics 02/16/2024 Examination, testing; scientifically valid
LXR Biotech Food and Cosmetics 02/16/2024 Document; laboratory methodology followed
Ol Pharma Technician, LLC Drugs 07/22/2024 Lack of quality control unit
Ol Pharma Technician, LLC Drugs 07/22/2024 Procedures not in writing, fully followed
Ol Pharma Technician, LLC Drugs 07/22/2024 Training–operations, GMPs, written procedures
Ol Pharma Technician, LLC Drugs 07/22/2024 Equipment Design, Size and Location
Ol Pharma Technician, LLC Drugs 07/22/2024 Cleaning / Sanitizing / Maintenance
Ol Pharma Technician, LLC Drugs 07/22/2024 Control procedures to monitor and validate performance
Ol Pharma Technician, LLC Drugs 07/22/2024 Scientifically sound laboratory controls
Ol Pharma Technician, LLC Drugs 07/22/2024 Lack of written stability program
Ol Pharma Technician, LLC Drugs 07/22/2024 Prepared for each batch, include complete information
Romd, LLC Devices 03/01/2024 Training – Lack of or inadequate procedures
Woodward Pharma Services, LLC Drugs 03/28/2024 Late submission of 15-day report
Woodward Pharma Services, LLC Drugs 03/28/2024 Submission of report follow-up
Woodward Pharma Services, LLC Drugs 03/28/2024 Failure to submit scientific article


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