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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