Lax process validation, inadequate control of nonconforming product and failure to implement CAPA procedures were a few of the concerns the FDA highlighted during an inspection of Mark Two Engineering’s Miami Lakes, Florida facility.
Process validation activities were found to be unacceptable because they didn’t include acceptance criteria, production records and inspection data records, the FDA said. Inspection records also lacked the operator’s initials and dates.
The agency investigators said that six of seven CAPA procedures were missing critical information, including root cause evaluation, effectiveness checks and corrective action plans. The 483 said the contract manufacturer of medical device components didn’t perform trending of complaints and nonconforming products.
For example, one complaint investigation identified the possible root cause as failure to follow proper line clearance procedures as an isolated occurrence. However numerous complaints also addressed this root cause failure, and complaints and CAPAs were not reviewed to determine if corrective actions were implemented, the agency said.
The contract manufacturer had not implemented procedures to control nonconforming products, not all material review record forms included the disposition of nonconforming products, and evaluations of the nonconforming products doesn’t include the need for an investigation.
Other observations on the eight-item 483 included failure to maintain equipment and supplier evaluations, and failure to establish procedures for receiving, reviewing and evaluating complaints by a formally designated unit.
Read the Mark Two Engineering Form 483 here: www.fdanews.com/11-07-19-marktwoengineeringinc483.pdf.
Changes to FDA Inspection Protocols
Since 2013, the FDA has been working toward a realignment of its inspection structure, including shifts in personnel as well as priorities.
The changes include an increased focus on inspectors with technical expertise around various kinds of medical devices and emerging technologies. In practice, this means devicemakers will see two inspectors at a time, rather than one. The first will be a general quality system investigator, while the second will be someone with specialized knowledge about the type of device a company manufactures — such as implantables, nanotechnology or stents.
Devicemakers should expect to always see one inspector who is extremely familiar with the type of device they’re making. John Avellanet, managing director and principal of Cerulean Associates suggests having a subject-area expert on hand for the inspection, someone who can answer technical questions and explain things to an inspector clearly.
This also means that if the subject-area expert goes on vacation, or is out sick, a backup expert should be available, or at least on call. For small companies, this might mean contacting a professor at a local university who helped develop the technology, or someone who did some testing and clinical trials for the product.
The agency has trained its investigators on the basics of data integrity, and it has plans to do more specialized data-integrity training as well as training in emerging technologies, such as 3D printing.
Companies that can demonstrate consistent quality benchmarks could see fewer regular inspections as a result of the FDA’s ongoing effort to better allocate its limited resources.
One of the top priorities for CDRH is to move toward “a culture of quality and organizational excellence,” according to Cisco Vicenty, program manager for the CDRH’s Case for Quality initiative. In practical terms, this means CDRH is Looking at how it can help drive a “quality mindset” within the medical device industry, strengthening product and manufacturing quality across the board.
Excerpted from the FDAnews management report: CDRH in Transition — Navigating the New Culture of Quality.