Thursday, April 2, 2020

Thursday, April 2, 2020

FDA Update: August inspection citations


The U.S. Food and Drug Administration 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 August

Company's Legal NameInspection End DateProgram AreaShort DescriptionLong Description
Paket CorpAug. 6, 2019DrugsProcedures not in writing, fully followedThe responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Paket CorpAug. 6, 2019DrugsWritten procedures fail to includeWritten procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance and instructions for protection of clean equipment from contamination prior to use.
Paket CorpAug. 6, 2019DrugsSOPs not followed / documentedWritten production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
Paket CorpAug. 6, 2019DrugsRecall facilitationA system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established.
Paket CorpAug. 6, 2019DrugsMaster production and control records, procedureThe preparation of your master production and control records was not described in a written procedure and followed in accordance with your written procedure.
Alt Medical DevicesAug. 2, 2019DevicesLack of Written MDR ProceduresWritten MDR procedures have not been developed and maintained.
Alt Medical DevicesAug. 2, 2019DevicesQuality audits - Lack of or inadequate proceduresProcedures for quality audits have not been established.
Alt Medical DevicesAug. 2, 2019DevicesEvaluation of suppliers, contractors, etc., requirementsRequirements that must be met by suppliers have not been established.
Alt Medical DevicesAug. 2, 2019DevicesLack of or inadequate procedures - Acceptance activitiesProcedures for acceptance activities have not been established.
Alt Medical DevicesAug. 2, 2019DevicesNonconforming product,Lack of or inadequate proceduresProcedures have not been established to control product that does not conform to specified requirements.
Alt Medical DevicesAug. 2, 2019DevicesLack of or inadequate proceduresProcedures for corrective and preventive action have not been established.
Alt Medical DevicesAug. 2, 2019DevicesLack of or inadequate procedures for labelingProcedures to control labeling activities have not been established.
Alt Medical DevicesAug. 2, 2019DevicesLack of or inadequate DHR proceduresProcedures for device history records have not been established.
Alt Medical DevicesAug. 2, 2019DevicesLack of or inadequate complaint

procedures

Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
Premium Foods USA Inc.Aug. 1, 2019FoodsSanitation RecordsYou are not maintaining sanitation control records that document monitoring and corrections of sanitation deficiencies for prevention of cross-contamination from insanitary objects, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals and exclusion of pests.
Maruju Seafood IncAug. 1, 2019FoodsCritical limitsYour HACCP plan lists a critical limit that does not ensure control of one or more hazards.
Maruju Seafood IncAug. 1, 2019FoodsVerification procedures - adequacyYour HACCP plan lists verification procedures that have not been developed in accordance with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety hazards, and is being effectively implemented.
Maruju Seafood IncAug. 1, 2019FoodsSanitation monitoringYou are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice and condition and cleanliness of food contact surfaces.
Source: U.S. Food and Drug Administration

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U.S. Food and Drug Administration (FDA)

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