Haney, the Packaging Microfactory, has completed a routine FDA Medical Device Assessment. The audit, facilitated by two FDA medical device inspectors, took place from October 22nd to 24th 2019. This three-day, on-site, inspection included a detailed facility tour and the review of company policies, employee training, and project documentation.
As a producer of small-batch, consumer usable product samples, this procedure established that Haney’s Cincinnati facility is compliant with the principles and guidelines code of federal regulations for medical device facilities. Closing remarks from investigators indicated no formal observations would be issued.
“We believe the results of this audit are excellent,” said Mike Sewak, Quality Manager at Haney, “This process not only verifies that our quality systems are effective but provides our clients with the confidence to know that Haney provides commercial product samples that are safe and legal.”
Haney is registered as a repackager/relabeler for 10 medical device listings including both feminine hygiene and dental devices.