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 a 46.2% decrease from the number of companies cited in the previous year.
Of the 26 citations issued, the most common citations were 'A qualified container closure inspection person did not record the observations made of the top seam of a can randomly selected from each seaming head and the container closures at intervals of sufficient frequency to ensure proper closure' and 'Procedures for corrective and preventive action have not been adequately established'.
Most of the companies cited were involved in either Devices or Food and Cosmetics sectors.
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 |
---|---|---|---|
Big Lots, Inc. | Food and Cosmetics | 03/22/2023 | LACF compliance |
Big Lots, Inc. | Food and Cosmetics | 03/22/2023 | Hazard analysis written |
Big Lots, Inc. | Food and Cosmetics | 03/22/2023 | Supplier verification - establish written procedures |
Big Lots, Inc. | Food and Cosmetics | 03/22/2023 | Verification activity frequency |
Dan the Baker, LLC | Food and Cosmetics | 03/01/2023 | Personnel |
Dan the Baker, LLC | Food and Cosmetics | 03/01/2023 | Plant construction and design |
Dan the Baker, LLC | Food and Cosmetics | 03/01/2023 | Sanitary facilities and controls |
GFS Chemicals, Inc. | Devices | 11/17/2023 | Lack/Inad procedure-Monitoring/Control of Validated Proces |
IncludeHealth | Devices | 11/01/2023 | Management review - Lack of or inadequate procedures |
IncludeHealth | Devices | 11/01/2023 | Quality audits - Lack of or inadequate procedures |
IncludeHealth | Devices | 11/01/2023 | Design validation - software validation not performed |
IncludeHealth | Devices | 11/01/2023 | Lack of or inadequate procedures |
IncludeHealth | Devices | 11/01/2023 | Lack of or inadequate complaint procedures |
Mars Petcare US, Inc. | Food and Cosmetics | 01/23/2023 | Frequency: visual closure examinations, record |
Mars Petcare US, Inc. | Veterinary | 01/23/2023 | Frequency: visual closure examinations, record |
Safecor Health, LLC | Drugs | 09/01/2023 | Identity Testing of Each Component |
Safecor Health, LLC | Drugs | 09/01/2023 | Absence of Written Procedures |
Safecor Health, LLC | Drugs | 09/01/2023 | Changes to Procedures Not Reviewed, Approved |
Safecor Health, LLC | Drugs | 09/01/2023 | Reprocessing/quality control unit |
Safecor Health, LLC | Drugs | 09/01/2023 | Sample size - test intervals |
Safecor Health, LLC | Drugs | 09/01/2023 | Written records kept in individual logs |
Safecor Health, LLC | Drugs | 09/01/2023 | Investigations of discrepancies, failures |
Vesco Medical, LLC | Devices | 10/31/2023 | Design control - no procedures |
Vesco Medical, LLC | Devices | 10/31/2023 | Purchasing controls, Lack of or inadequate procedures |
Vesco Medical, LLC | Devices | 10/31/2023 | Lack of or inadequate procedures |
Vesco Medical, LLC | Devices | 10/31/2023 | Investigation of device failures |