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Friday, October 4, 2024

FDA: 4 companies in cities within Milwaukee County received 16 citations in Q4 2023

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James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

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

This is unchanged from the number of companies cited in the previous quarter.

Of the 16 citations issued, the most common citation was 'You did not conduct and document your hazard analysis'.

Most 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.

Companies located within Milwaukee County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
Athea Laboratories, Inc.Drugs12/20/2023Mfg / Processing Operations Area
Athea Laboratories, Inc.Drugs12/20/2023Component identification test
Colectivo Coffee Roasters, Inc.Food and Cosmetics11/07/2023Hazard analysis - Conducted
Colectivo Coffee Roasters, Inc.Food and Cosmetics11/07/2023Supply-chain program - Establish
Neptune Sandwiches, Inc.Food and Cosmetics10/11/2023Hazard analysis - Conducted
Neptune Sandwiches, Inc.Food and Cosmetics10/11/2023HACCP plan implementation
Neptune Sandwiches, Inc.Food and Cosmetics10/11/2023Monitoring - adequacy
Neptune Sandwiches, Inc.Food and Cosmetics10/11/2023Corrective action plan
Neptune Sandwiches, Inc.Food and Cosmetics10/11/2023Verification procedures - adequacy
Neptune Sandwiches, Inc.Food and Cosmetics10/11/2023Signed and dated
Penzeys, Ltd.Food and Cosmetics10/12/2023Sanitary operations - Plant sanitation
Penzeys, Ltd.Food and Cosmetics10/12/2023Hazard analysis - Identification of hazard
Penzeys, Ltd.Food and Cosmetics10/12/2023Allergen preventive controls - Implement
Penzeys, Ltd.Food and Cosmetics10/12/2023Sanitation preventive controls - Implement
Penzeys, Ltd.Food and Cosmetics10/12/2023Allergen preventive controls - Appropriate (Adequate)
Penzeys, Ltd.Food and Cosmetics10/12/2023Supply-chain program - Assurance (Adequate)

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