Devices

Multiple Violations at Indonesia’s P.T. Sankei

A 5/8-5/11/2023 FDA inspection at the P.T. Sankei Medical Industries manufacturing facility in Banten, Indonesia, found Quality System and Medical Device Reporting violations in its manufacturing of adulterated and misbranded medical devices. A just-released 9/19/2023 Warning Letter says the company manufactures a sphygmomanometer unit that is adulterated because the firm changed the materials of the device cleared in a 510(k) without submitting a new 510(k).

The letter says the device also is misbranded because Sankei did not notify FDA of its intent to introduce the device into commercial distribution.

Quality System violations identified in the inspection were:

failure to establish and maintain adequate procedures to control the design of the device to ensure that specified design requirements are met;
failure to adequately establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
failure to adequately ensure device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured following the device master record and the requirements of this part;
failure to adequately maintain device master records;
failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failure to establish procedures for quality audits and conduct such audits to assure that the quality system complies with the established quality system requirements and to determine the effectiveness of the quality system.

The Medical Device Reporting violation described in the letter was the failure to adequately develop, maintain, and implement written medical device reporting procedures.

FDA says the firm’s responses to the inspection observations were inadequate.

P.T. Sankei was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.

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