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.
FDA Inspection Citation Details for August
|Company's Legal Name||Inspection End Date||Program Area||Short Description||Long Description|
|Paket Corp||Aug. 6, 2019||Drugs||Procedures not in writing, fully followed||The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.|
|Paket Corp||Aug. 6, 2019||Drugs||Written procedures fail to include||Written 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 Corp||Aug. 6, 2019||Drugs||SOPs not followed / documented||Written 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 Corp||Aug. 6, 2019||Drugs||Recall facilitation||A 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 Corp||Aug. 6, 2019||Drugs||Master production and control records, procedure||The 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 Devices||Aug. 2, 2019||Devices||Lack of Written MDR Procedures||Written MDR procedures have not been developed and maintained.|
|Alt Medical Devices||Aug. 2, 2019||Devices||Quality audits - Lack of or inadequate procedures||Procedures for quality audits have not been established.|
|Alt Medical Devices||Aug. 2, 2019||Devices||Evaluation of suppliers, contractors, etc., requirements||Requirements that must be met by suppliers have not been established.|
|Alt Medical Devices||Aug. 2, 2019||Devices||Lack of or inadequate procedures - Acceptance activities||Procedures for acceptance activities have not been established.|
|Alt Medical Devices||Aug. 2, 2019||Devices||Nonconforming product,Lack of or inadequate procedures||Procedures have not been established to control product that does not conform to specified requirements.|
|Alt Medical Devices||Aug. 2, 2019||Devices||Lack of or inadequate procedures||Procedures for corrective and preventive action have not been established.|
|Alt Medical Devices||Aug. 2, 2019||Devices||Lack of or inadequate procedures for labeling||Procedures to control labeling activities have not been established.|
|Alt Medical Devices||Aug. 2, 2019||Devices||Lack of or inadequate DHR procedures||Procedures for device history records have not been established.|
|Alt Medical Devices||Aug. 2, 2019||Devices||Lack of or inadequate complaint
|Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.|
|Premium Foods USA Inc.||Aug. 1, 2019||Foods||Sanitation Records||You 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 Inc||Aug. 1, 2019||Foods||Critical limits||Your HACCP plan lists a critical limit that does not ensure control of one or more hazards.|
|Maruju Seafood Inc||Aug. 1, 2019||Foods||Verification procedures - adequacy||Your 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 Inc||Aug. 1, 2019||Foods||Sanitation monitoring||You 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.|