FDA inspectional observations

Below list provide examples of investigational observations issued by FDA to medical device establishments in recent years. You can search warning letters at FDA 483 database.

• Incomplete documentation of calibration dates for measurement and test equipment.
• Procedures for acceptance or rejection of incoming product were not implemented.
• Complaint handling procedures have not been implemented.
• Records of complaint investigations do not include the results of the investigation.
• Complete complaint files are not maintained.
• All complaints are not processed in a uniform and timely manner.
• Quality audits were not conducted at sufficient regular intervals.
• Corrective and preventive action activities have not been documented.
• The procedures for implementing corrective and preventive actions were not defined and complete.
• Written MDR procedures have not been maintained.
• The device history record does not include complete acceptance records.
• The device history record does not include the primary identification label and labeling for each device.
• The device history record does not demonstrate the device is manufactured in accordance with the device master record.
• Records of acceptable suppliers and consultants were not maintained.
• Supplier evaluation not documented.
• Purchase procedure not established.
• Procedures for controlling the storage of product in storage areas and stock rooms were not established to prevent mix-ups.
• A design and development plan has not been established.
• Process control procedures are not established and implemented.
• No management representative had been appointed to ensure that quality system requirements are met.
• Procedures for management review are not complete.
• Procedures for management review are not established, defined, and documented.
• Incomplete documentation of the disposition of nonconforming product.
• Procedures for rework of nonconforming product were not defined, documented, and implemented.
• Employees have not been adequately trained.
• Procedures for training and identifying training needs have not been adequately established.
• The quality policy and objectives were not defined and documented.
• Quality system procedures were not complete.
• Required records are not legible.
• Documents does not include the approval date and signature.
• Validation procedure not established.
• Procedures have not been established to ensure that expired or deteriorated devices are not distributed.