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.
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.|