Life Sciences

C.R. Bard receives FDA warning letter

Device Regulation Alert: Safety, Compliance and Reimbursement News, October 20, 2008

The FDA cited C.R. Bard for failing to meet current Good Manufacturing Practices at its Humacao, Puerto Rico–based  facility in a warning letter.
 
According to the FDA, C.R. Bard failed to:
  • Establish and maintain procedures for identifying product during all stages
  • Establish and maintain procedures to control product that does not conform to specified requirements
  • Implement and record changes needed to correct and prevent identified quality problems
  • Retain all required records
  • Establish procedures for receiving and reviewing complaints
  • Conduct timely audits
 
The FDA also said it reviewed the company’s responses to the noted violations and found the responses to be inadequate.

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