When adulterated products are manufactured in a foreign establishment, don’t expect FDA to admit them into the country.
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.
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?
The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.
Training is not a nice-to-have; it’s a fundamental requirement.
You must respond within 15 days, and you must show FDA how your establishment will be brought back to compliance.