Devices

Multiple Violations in Bioptimal Inspection

An 11/6-11/11/2023 FDA inspection at China’s Bioptimal International manufacturing facility in Singapore identified Unapproved Device, Quality System Regulation, and Medical Device Reporting violations in the firm’s manufacturing of the Thermodilution Catheter and Pulmonary Artery Monitoring Catheter. A just-released 4/3 Warning Letter says both catheters are adulterated because the firm does not have an approved PMA or IDE in effect for them. It also says they are misbranded because Bioptimal did not notify FDA of its intent to introduce the devices into commercial distribution.

Quality System violations were identified as:

failure to adequately maintain complaint files and establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failure to establish and maintain procedures for implementing corrective and preventive action, specifically verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
failure to establish and maintain procedures to validate device design to ensure that devices conform to defined user needs and intended uses, and include risk analysis where appropriate;
failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure; and
failure to establish and maintain device history record (DHR) procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured following the device master record.

The two Medical Device Reporting (MDR) violations were:

failure to adequately develop, maintain, and implement written MDR procedures; and
failure to submit a report to FDA no later than 30 calendar days after the day that the firm received or otherwise became aware of information, from any source, that reasonably suggested that a device the firm markets may have caused or contributed to a death or serious injury.

Bioptimal was told to respond with a list of specific steps it has taken to address all the violations and prevent their recurrence, with documentation of each step and a schedule for completing the corrections.

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