FDA Warning Letter — Criticare Systems (Malaysia) Sdn. Bhd.

Case 445485 — FEI 3008727514

The FDA took a Warning Letter action against Criticare Systems (Malaysia) Sdn. Bhd. on January 15, 2015 (Nusajaya, Malaysia). The action was issued by CDRH and concerns devices products. This facility has 2 recent FDA inspections on record.

Action Details

Facility
Criticare Systems (Malaysia) Sdn. Bhd.
Date
January 15, 2015
Fiscal Year
2015
Product Type
Devices
Center
CDRH
Location
Nusajaya (Malaysia)