FDA issued Warning Letters to Beckman Coulter - 2011

[AnaMariaVR2]

FDA issued warning letters to Beckman Coulter for violations on:

1. CAPA
2. Failure Investigations
3. Complaint Handling
4. Training
5. Medical Device Reporting

Warning letter: FDA unleashes laundry list of accusations against Beckman Coulter

Beckman Coulter, Inc. 8/9/11 [W/L 48-11]

FDA Sends Warning Letter To Danaher's Beckman Coulter Unit

Beckman Coulter, Inc. 11/1/11 [FLA-12-07]

Beckman Coulter Receives FDA Warning Letter

 

[Ajit Basrur]

Ana,

Thanks for keeping us posted. These would be Lessons Learned for all of us.