The FDA flagged Integrity Systems for a combination of incomplete records, inadequate process validation and software problems.
The agency issued a Form 483 after a May/June inspection of the devicemaker’s Olive Branch, Miss., facility. The facility’s device history records did not demonstrate the devices were made in accordance with device master records in at least three cases.
Investigators also found the firm’s procedures did not address documentation and monitoring of processing times for all processes or document processing times.
In addition, the facility failed to validate the software it used for management of inventory and documentation of quality system records.