The FDA cited 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 documentation of CAPA procedures. 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 the 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.