Medical Device GMP Enforcement

FDA 2011 Medical Device GMP Enforcement

Quality System Regulation - 21 CFR Part 820 - Click Here

Medical Devices - Warning Letters

Tosoh Biosiences ... January 18, 2011

Multiple GMP Violations on Complaint Handling, Failure Investigations, CAPA, and more. Help ensure your company's compliance with current FDA GMP-related enforcement with enKap's content packages.

Costumes For Your Eyes ...January 24, 2011

"Failure to establish and maintain a quality system that is appropriate for the specific medical device designed or manufactured, as required by 21 CFR 820.5. For example, your firm did not establish a quality system. Procedures regarding management controls, designed controls, corrective and preventive actions, or production and procedures for documenting complaint handling activities, supplier controls, or control of non-conforming products."

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Tra & Accessories ... February 1, 2011

Aid United International Co. Limited... February 3, 2011

Coastal Implant Technologies, Inc. ...February 3, 2011

Excerpt: Related to your supplier, "your firm does not have a written agreement... covering specifications and responsibilities"

Southern Implants, (Pty.) Ltd. ... February 7, 2011

Multiple CAPA, Complaint Handling and Failure Investigation violations. Excerpts from this warning letter include:

"Not all quality data sources are being monitored...to identify sources of nonconformance for corrective actions."

"...no documented investigation to determine the root cause."

"Your firm did not provide documentation...to ensure that corrective and preventive action are implemented as required."

Customer complaint: "The complaint was confirmed and the staff retrained but there was no documented investigation to determine the root cause."

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RD Medical Manufacturing, Inc. ... February 7, 2011

Multiple complaint handling and failure investigation-related violations, including:

"...your distributor indicated that they received a complaint for lot... for the same defect and you did not extend your investigation to evaluate this lot."

"You also failed to extend your investigation to other lots with the same product code to check for defects. Moreover, you did not provide documentation for an analysis of the risk associated with the reported defect and its effect on product distribution."

Training - Related Violations:

"you failed to provided documentation showing that the operators performing the technique... have been certified to perform function."

"you failed to... show that your operators have been trained in the techniques described above"

Tyco Healthcare Canada... February 14, 2011

"Your firm has not ensured that the identified corrective action is being implemented by the supplier"

Medela Inc. ... February 25, 2011