The FDA wants to know that rework activities are not impacting product safety and efficacy issues or influencing long-term product reliability.
It is our responsibility to educate family and friends about the dangers associated with the practicing of backroom medicine.
It is one of the most basic of quality requirements.
Procedures for design validation must address risk analysis where appropriate.
When it comes to adverse event reporting, the FDA does not grant exemptions.
In pursuit of the almighty dollar, this case involves the smuggling of lamb fat.
When FDA says stop, they mean stop!
All equipment must be qualified and calibrated for its intended use.
Can your company prove its device has been manufactured in accordance with its DMR?
Managing suppliers is critical, and your processes in doing so must be documented.