Tuesday, December 10, 2019

Tuesday, December 10, 2019

FDA Update: September inspection citations


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 NameInspection End DateProgram AreaShort DescriptionLong Description
Chicago KimcheeSept. 5, 2019FoodsPersonnelYou did not take a reasonable measure and precaution related to personnel practices.
Chicago KimcheeSept. 5, 2019FoodsSanitary Operations - Plant MaintenanceYou did not maintain your plant in a clean and sanitary condition and keep your plant in repair.
Chicago KimcheeSept. 5, 2019FoodsCleaning 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 KimcheeSept. 5, 2019FoodsPest ControlYou did not exclude pests from your food plant to protect against contamination of food.
Chicago KimcheeSept. 5, 2019FoodsEquipment and Utensils - Design and MaintenanceYour 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 CenterSept. 4, 2019BiologicsProof of IdentityFailure 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, LLCSept. 3, 2019DevicesProcess 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, LLCSept. 3, 2019DevicesEquipment control activity documentationEquipment has not been documented.
Apothecary Products, LLCSept. 3, 2019DevicesLack of or inadequate receiving acceptance proceduresProcedures for acceptance of incoming product have not been adequately established.
Source: U.S. Food and Drug Administration

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