The FDA issued 483s to three device facilities for a variety of deficiencies including design control procedures, data integrity, CAPAs and complaint handling.
Elite Medical Supply of New York: The FDA cited Elite Medical Supply of New York for problems with its design control procedures and handling of CAPAs and complaints.
Investigators issued the Form 483 after a December 2017 inspection of the device specification developer’s West Seneca, New York facility. They found the design for the company’s Elite Medical Multi-Mode Stimulator was bought from another company but that Elite Medical did not document a review or approval of the design history file to ensure completeness and accuracy. Moreover, the company had no procedures for introducing outside designs.
Investigators also found that procedures for design validation did not include any requirement to demonstrate equivalency to the production units.
The agency also found that several complaints were reviewed for units identified as “dead on arrival” due to batteries not being charged ahead of shipment. The firm’s quality assurance manager said a corrective action was taken to prevent the problem, but this was not documented in a CAPA.
The company’s complaint-handling procedures also did not require documenting the complainant’s address or phone number, replies to the complainant or dates of the subsequent investigation. At least one of the complaint reports also lacked complainant information.
Ivoclar Vivadent: The FDA issued a Form 483 to Ivoclar Vivadent for noncompliant process control procedures, CAPA procedures and test/measurement equipment.
The agency issued the form after a January 2018 inspection of the company’s Amherst, NY, facility.
Investigators found the company’s soldering, press operation and foil production facilities, did not comply with procedures requiring operators to use the correct stamp for the alloy or solder being cut and stamped. The document identifying the approved stamps for each alloy and solder was retired on July 14, 2017 and an approved list was not put back in place until January 9, 2018, the agency said.
The FDA also found that several CAPAs reviewed did not include documentation for corrective actions addressing the identified root causes. Some corrective actions only documented the effectiveness check submitted to close the CAPA. Some corrective actions did not properly document review and acceptance ahead of implementation.
The investigators also observed that the company did not properly evaluate whether problems with accuracy in its test/measurement equipment had any negative impact on the quality of the devices.
Veran Medical Technologies: The FDA hit Veran Medical Technologies on handling of CAPAs and complaints as well as its documentation of acceptance activities.
The agency issued a Form 483 after a March 2018 inspection of the device manufacturer’s Saint Louis, Missouri facility. It found the facility did not properly document that the corrective actions it took did not adversely affect products and that it failed to adequately document that the corrective actions eliminated the problem.
The company also failed to follow its complaint review procedures and did not log at least five calls that should have been documented as potential complaints.
Moreover, the company’s receiving inspection report for at least one lot did not have the required signatures of personnel responsible for the inspections.
The FDA investigators also found device history records for Veran’s SPiNView System did not include primary identification labels and labeling used for each production units, and that the facility did not conduct onsite audits to evaluate its critical suppliers.
The company also improperly labeled class IV accessible laser radiation devices and did not submit product reports prior to introduction of the SPiNView System. It also failed to submit an annual report for the system.
Read the three Form 483s here: www.fdanews.com/05-30-18-ThreeForm483s.pdf. — Zack Budryk
Personnel Requirements for CAPA Teams
Companies putting together CAPA teams will need to assign the following individuals:
Excerpted from the FDAnews management report: Creating QSR-Compliant CAPA Systems: A Practical Guide for Devicemakers.