75 Executive Drive, Suite 114, Aurora, Illinois, USA - 60504

Phone : (630) 270-2921
E-mail : info@fdahelp.us

FDA 483 warning letter

FDA issue a warning letter if found the establishment is not in compliance with GMP regulations after inspection. It is always better to know the common situation which FDA consider as a non-compliance. Most of the time the lack of proper documentation, record or evidence lead to warning letter.

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.

Contact Us

75 Executive Drive, Suite 114
Aurora, Illinois, USA - 60504
Phone : (630) 270-2921
Fax : (815) 986-2632
E-mail : info@fdahelp.us