There were 11 companies in cities associated with Milwaukee County that received FDA citations as a result of 11 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).
This is an 8.3% decrease from the number of companies cited in the previous year.
Of the 38 citations issued, the most common citations were ‘You did not conduct and document your hazard analysis’ and ‘You did not develop an FSVP’.
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 the Devices sector.
Of the companies cited, 10 should take voluntary actions to correct their managing operations (90.9%). Additionally, one company had to take regulatory and/or administrative actions (9.1%).
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 |
|---|---|---|---|
| Athea Laboratories, Inc. | Drugs | 12/20/2023 | Mfg / Processing Operations Area |
| Athea Laboratories, Inc. | Drugs | 12/20/2023 | Component identification test |
| Avanti Foods Corporation | Food and Cosmetics | 10/11/2023 | Hazard analysis – Conducted |
| Avanti Foods Corporation | Food and Cosmetics | 10/11/2023 | HACCP plan implementation |
| Avanti Foods Corporation | Food and Cosmetics | 10/11/2023 | Monitoring – adequacy |
| Avanti Foods Corporation | Food and Cosmetics | 10/11/2023 | Corrective action plan |
| Avanti Foods Corporation | Food and Cosmetics | 10/11/2023 | Verification procedures – adequacy |
| Avanti Foods Corporation | Food and Cosmetics | 10/11/2023 | Signed and dated |
| Colectivo Coffee Roasters, Inc. | Food and Cosmetics | 11/07/2023 | Hazard analysis – Conducted |
| Colectivo Coffee Roasters, Inc. | Food and Cosmetics | 11/07/2023 | Supply-chain program – Establish |
| Creation Technologies Wisconsin, Inc. | Devices | 07/20/2023 | Evaluation of suppliers, contractors, etc., requirements |
| Creation Technologies Wisconsin, Inc. | Devices | 07/20/2023 | Process control procedures, Lack of or inadequate procedures |
| Creation Technologies Wisconsin, Inc. | Devices | 07/20/2023 | Equipment control activity documentation |
| Diaspora Tea & Herb Company, LLC | Food and Cosmetics | 08/29/2023 | Document review entity’s hazard analysis |
| Diaspora Tea & Herb Company, LLC | Food and Cosmetics | 08/29/2023 | Evaluation – performance, risk |
| Diaspora Tea & Herb Company, LLC | Food and Cosmetics | 08/29/2023 | Approved supplier procedures – importer established |
| Diaspora Tea & Herb Company, LLC | Food and Cosmetics | 08/29/2023 | Verification activity assurance |
| Diaspora Tea & Herb Company, LLC | Food and Cosmetics | 08/29/2023 | Verification activity frequency |
| Diaspora Tea & Herb Company, LLC | Food and Cosmetics | 08/29/2023 | Identification – entry |
| GE Healthcare – Repair Operations Center | Devices | 07/18/2023 | Lack of or inadequate procedures |
| Indian Groceries and Spices, Inc. | Food and Cosmetics | 07/21/2023 | Develop FSVP |
| MDS Fulfillment, Inc. | Food and Cosmetics | 06/14/2023 | Physical plant – repair |
| MDS Fulfillment, Inc. | Food and Cosmetics | 06/14/2023 | Written procedures – cleaning |
| MDS Fulfillment, Inc. | Food and Cosmetics | 06/14/2023 | Written procedures – pest control |
| MDS Fulfillment, Inc. | Food and Cosmetics | 06/14/2023 | Written procedures – holding; distributing |
| MDS Fulfillment, Inc. | Food and Cosmetics | 06/14/2023 | Written procedures – returned dietary supplement; salvaged |
| MDS Fulfillment, Inc. | Food and Cosmetics | 06/14/2023 | Grounds |
| Midwest Products and Engineering, Inc. | Devices | 04/21/2023 | Management ensuring quality policy is understood |
| Midwest Products and Engineering, Inc. | Devices | 04/21/2023 | Environmental control Lack of or inadequate procedures |
| Midwest Products and Engineering, Inc. | Devices | 04/21/2023 | Product rework documentation, DHR {see also 820.184} |
| Midwest Products and Engineering, Inc. | Devices | 04/21/2023 | Documentation |
| Penzeys, Ltd. | Food and Cosmetics | 10/12/2023 | Sanitary operations – Plant sanitation |
| Penzeys, Ltd. | Food and Cosmetics | 10/12/2023 | Hazard analysis – Identification of hazard |
| Penzeys, Ltd. | Food and Cosmetics | 10/12/2023 | Allergen preventive controls – Implement |
| Penzeys, Ltd. | Food and Cosmetics | 10/12/2023 | Sanitation preventive controls – Implement |
| Penzeys, Ltd. | Food and Cosmetics | 10/12/2023 | Allergen preventive controls – Appropriate (Adequate) |
| Penzeys, Ltd. | Food and Cosmetics | 10/12/2023 | Supply-chain program – Assurance (Adequate) |
| Sasta Bazaar, Inc. | Food and Cosmetics | 02/22/2023 | Develop FSVP |
