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
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.
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 |
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 |
Neptune Sandwiches, Inc. | Food and Cosmetics | 10/11/2023 | Hazard analysis - Conducted |
Neptune Sandwiches, Inc. | Food and Cosmetics | 10/11/2023 | HACCP plan implementation |
Neptune Sandwiches, Inc. | Food and Cosmetics | 10/11/2023 | Monitoring - adequacy |
Neptune Sandwiches, Inc. | Food and Cosmetics | 10/11/2023 | Corrective action plan |
Neptune Sandwiches, Inc. | Food and Cosmetics | 10/11/2023 | Verification procedures - adequacy |
Neptune Sandwiches, Inc. | Food and Cosmetics | 10/11/2023 | Signed and dated |
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) |