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.
APRIL FOOL’S! FDA inspectors don’t want to discover hungry rodents enjoying a meal of device history records.
Failure to comply with FDA’s wishes landed three companies warning letters.
Audits are the cornerstone of a QMS.
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.
FDA requires that manufactures establish and maintain procedures regarding labeling activities.