P.T. Sankei Medical Industries

Warning LetterOpen

IndonesiaFEI 3001576493Issued Sep 19, 2023Center for Devices and Radiological Health

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3001576493.

Violations0

Issue DateSep 19, 2023

Product TypeDevices

StatusOpen

Letter Details

Firm: P.T. Sankei Medical Industries
Location: Indonesia
FEI Number: 3001576493
Country: Indonesia
Issue Date: September 19, 2023
Issuing Office: Center for Devices and Radiological Health
Product Type: Devices
Status: Open

Summary

Based on limited metadata from this FDA Warning Letter, P.T. Sankei Medical Industries, a medical device manufacturer, received a warning from the FDA on September 19, 2023. While the specific subject line and detailed violation count are unavailable, the warning indicates regulatory concerns regarding the company's medical devices. Without access to the full letter text, the precise nature of the violations cannot be determined, though they fall within the FDA's medical device regulatory authority.

P.T. Sankei Medical Industries FDA Warning Letter, September 19, 2023