483 Roundup: FDA Cites Four Firms Over Complaints, CAPAs

September 8, 2017

The FDA issued Form 483s to four device manufacturers for issues ranging from responses to customer complaints to record-keeping.

Aero Data Metal Crafters: The FDA hit Aero Data Metal Crafters for inadequate complaint procedures and device history records.

The agency issued a Form 483 to the devicemaker following a June inspection of its Ronkonkoma, NY, facility. According to investigators, the facility did not have medical device reporting procedures for its mammography positioning chair model MPC1000-E, a class I device.

The firm also did not maintain paper or scanned copies of the signed and reviewed device history records for the MPC1000-E, and did not keep labeling records for the device.

The agency also faulted Aero Data on its handling of complaints, noting that its complaint SOPs did not specify the procedure for receipt, review, evaluation and documentation to determine whether CAPAs were necessary.

In addition, the company did not document the CAPA process and a follow-up investigation for at least one rejection report received as part of a 2016 complaint.

American Dental Implant Corporation: American Dental Implant Corporation landed an FDA reprimand for its complaint files, MDR procedures and equipment calibration.

The FDA issued a Form 483 to the devicemaker after a July inspection of its New Castle, Pa., facility. The company, which manufactures dental implants, abutments and bone drills, did not document all complaints it receives or evaluate the undocumented complaints, according to the agency. The company also had no written MDR procedures.

The agency further cited the company for its lack of CAPA or design control procedures.

Caliber Imaging and Diagnostics: The FDA cited Caliber Imaging and Diagnostics over its device software validation, CAPA procedures and design verification.

The agency hit the medical device manufacturer with a Form 483 after a May/June inspection of its Rochester, NY, facility. Investigators found the software validation for an update to one of its products, signed off in September 2016, left multiple sections blank or crossed out with no justification. In the case of some tests that were noted to have failed, the facility did not maintain a record or defect report, the agency said.

The FDA also took issue with the software used during production, noting the company’s documentation did not include procedures for validation.

Investigators reviewed 12 CAPA records and found several were not verified or validated as effective. In addition, a revision to the company’s CAPA procedures did not include a requirement to validate or verify CAPAs to ensure there were no adverse effects.

Lastly, investigators found verification records for the company’s VivaScope 3000 Product Trace Matrix did not specify the verification method used.

Adroit Medical Systems: The FDA issued a Form 483 to Adroit Medical Systems for its recordkeeping and device history record procedures.

The agency issued the form following a July inspection of the devicemaker’s Loudon, Tenn., facility. It found that the firm’s device history record did not indicate that its class II heat therapy pump was manufactured according to the device master record.

Read the Aero Data Metal Crafters Form 483 here: www.fdanews.com/09-07-17-aerodata483.pdf.

Read the American Dental Implant Corporation Form 483 here: www.fdanews.com/09-07-17-americandental483.pdf.

Read the Caliber Imaging and Diagnostics Form 483 here: www.fdanews.com/09-07-17-caliber483.pdf.

Read the Adroit Medical Systems Form 483 here: www.fdanews.com/09-07-17-adroit483.pdf. — Zack Budryk