A Seattle, Washington devicemaker drew a Form 483 after a March inspection by the FDA revealed the facility lacked procedures for medical device reporting and had other significant nonconformances.
The agency noted that The Feminina Group had no procedure for medical device reporting and its complaint procedures did not include an evaluation for MDR.
The firm also lacked a procedure for performing quality audits and had no documentation showing that quality audits were being performed. The investigator observed that the company had no procedure for performing management reviews and there was no any evidence of any management reviews being performed.
In addition, the firm indicated that it had no procedure for design control or corrective and preventive actions.
The facility’s device history records did not include the quantity manufactured, primary identification labels or labeling used for each production unit. Also, the company could not provide a device master record for a product it manufactured.
The firm also indicated that it had no procedure for supplier control or purchasing, and no documentation showing the firm evaluated and approved its current contract manufacturer.