483 Roundup: FDA Cites Three Device Firms for CAPAs, Complaints

September 1, 2017

The FDA issued Form 483 reports to three devicemakers over inadequate CAPAs, complaint handling and other deficiencies.

Michael D. Williams: A Florida device specification developer lacked adequate CAPA procedures, complaint files and sampling plans, according to the FDA.

The FDA issued a Form 483 to Michael D. Williams’ Davie, Florida, facility following a June inspection. According to investigators, the office’s CAPA procedures lacked requirements for ensuring information on quality problems was properly transmitted to those responsible for ensuring quality.

The office also left key information out of complaint files, including device names, dates complaints were received, and complainant addresses and phone numbers. More than 600 complaints of 1,089 logged between November 2014 and June 2017 did not specify the nature and details of the complaint.

The agency also hit the company on its design control procedures, noting the procedures failed to ensure that ensure the design addresses the intended device use.

The company had no procedures for quality audits or purchasing control, and did not keep records of its evaluation of label printers or package suppliers. The firm’s sampling plans for its device mouthpiece fit testing was not based on a statistical rationale, and the facility lacked written procedures to control labeling activities.

The company also had no written procedures for re-packaging or document approval.

Biolife: Florida-based Biolife drew a Form 483 with four observations following a June 2017 FDA inspection. The investigator flagged the Sarasota facility’s inadequate design change documentation and medical device reporting procedures.

The firm had failed to report information from customer complaints to the FDA that appeared to meet the definition of adverse events, the agency said.

The facility also lacked procedures for corrective and preventive actions, and the firm failed to take appropriate action to prevent the recurrence of quality problems. One CAPA initiated for out -of -specification results during calibration of equipment, said the equipment had been out of tolerance for a fourth consecutive year.

Healthline Medical Products: The FDA flagged Healthline Medical Products for six deficiencies identified in a June 2017 inspection of the firms’ facility in Winter Garden, Florida, including CAPA problems, complaint investigations, product specifications, supplier evaluations, and device history records.

The FDA inspector found inadequate CAPA documentation of CAPA procedures. For example, the firm failed to validate corrective actions taken in response to a complaint involving a shower chair device that was determined to have been damaged during shipment. The corrective actions included training employees to use the proper amount of packaging material and developing a new package insert to caution users to inspect devices for damage upon receipt.

In addition, the firm’s records of complaint evaluations did not consistently include all the relevant details of the4 complaint and the investigation.

The facility also failed to ensure that all purchased products and services conformed to specifications and the evaluation of potential suppliers was not documented.

Finally, the facility’s device history record did include all device labeling. For example, the records did not refer to the package insert on cleaning instructions or to the insert covering inspection of the device for damage.

Read the Biolife Form 483 here: www.fdanews.com/08-31-17-biolifellc.pdf.

Read the Healthline Medical Products Form 483 here: www.fdanews.com/08-31-17-healthlinemedicalproductsinc.pdf.

Read the Michael D. Williams Form 483 here: www.fdanews.com/08-31-17-michaeldwilliamsddspa.pdf. — Zack Budryk and Ana Mulero