The U.S. Food and Drug Administration (FDA) inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.
The aim of publishing companies’ inspection data is to encourage compliance with related laws and regulations and give the public a window into the agency’s enforcement activities, according to the FDA. The agency’s public database on inspections is not comprehensive, however, since some information is not published until a final enforcement ruling is formulated.
Inspections carried out by states, as well as examinations of nonclinical laboratories and mammography facilities, are not included.
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FDA Inspection Citation Details for September
| Company's Legal Name | Inspection End Date | Program Area | Short Description | Long Description |
| Chicago Kimchee | Sept. 5, 2019 | Foods | Personnel | You did not take a reasonable measure and precaution related to personnel practices. |
| Chicago Kimchee | Sept. 5, 2019 | Foods | Sanitary Operations - Plant Maintenance | You did not maintain your plant in a clean and sanitary condition and keep your plant in repair. |
| Chicago Kimchee | Sept. 5, 2019 | Foods | Cleaning and sanitizing
substances - safe and adequate | You did not ensure that your cleaning compounds and sanitizing agents are safe and adequate under the conditions of use. |
| Chicago Kimchee | Sept. 5, 2019 | Foods | Pest Control | You did not exclude pests from your food plant to protect against contamination of food. |
| Chicago Kimchee | Sept. 5, 2019 | Foods | Equipment and Utensils - Design and Maintenance | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Hoxworth Blood Center University of Cincinnati Medical Center | Sept. 4, 2019 | Biologics | Proof of Identity | Failure to obtain from the donor on the day of donation a postal address where the donor may be contacted for 8 weeks after donation. |
| Apothecary Products, LLC | Sept. 3, 2019 | Devices | Process control procedures, lack
of or inadequate procedures | Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established. |
| Apothecary Products, LLC | Sept. 3, 2019 | Devices | Equipment control activity documentation | Equipment has not been documented. |
| Apothecary Products, LLC | Sept. 3, 2019 | Devices | Lack of or inadequate receiving acceptance procedures | Procedures for acceptance of incoming product have not been adequately established. |
