QS Violations at China’s Unimicro Medical Systems

A 9/15-9/26/21 FDA inspection at Unimicro Medical Systems-Shenzhen Co., Shenzhen, China, found Quality System Regulation violations in the firm’s manufacturing of Veress pneumoperitoneum needles. A just-released 1/6 Warning Letter says specific violations were: 

•          failing to adequately establish and maintain procedures to control product that does not conform to specified requirements;
•          failing to adequately establish and maintain procedures to control the design of the device to ensure that specified design requirements are met;
•          failing to adequately establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met;
•          failing to adequately establish and maintain procedures for implementing corrective and preventive action;
•          failing to adequately establish and maintain procedures to ensure that equipment is routinely calibrated, checked, and maintained;
•          failing to adequately establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met;
•          failing to adequately establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured following the device history record; and
•          failing to maintain device master records.

The letter says the firm’s responses to the inspection observations were inadequate or FDA could not determine their adequacy.

FDA says the needles manufactured by the company appear to be adulterated due to the serious nature of the violations and thus the agency was taking steps to refuse entry of the devices into the U.S.

Unimicro was told to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of the corrective actions and a schedule for completing the work.

The letter concludes that the violations noted in the letter and FDA-483 “may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.”